Acetaminophen Pm Extra Strength

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Acetaminophen Pm Extra Strength Recall

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Side Effects & Adverse Reactions

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age

Ask a doctor before use if you have

liver disease
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away: Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age

Ask a doctor before use if you have

liver disease
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Acetaminophen Pm Extra Strength Manufacturers

Safeway, Inc.

Acetaminophen Pm Extra Strength | Safeway, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours. children under 12 years: do not use

No Recall
Sam’s West Inc

Acetaminophen Pm Extra Strength | Sam's West Inc

do not take more than directed
adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours children under 12 years: do not use

No Recall
Chain Drug Marketing Association Inc

Acetaminophen Pm Extra Strength | Chain Drug Marketing Association Inc

do not take more than directed adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours children under 12 years: do not use

No Recall
Supervalue Inc.

Acetaminophen Pm Extra Strength | Supervalue Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Army And Air Force Exchange Service

Acetaminophen Pm Extra Strength | Army And Air Force Exchange Service

do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Winco Foods, Llc

Acetaminophen Pm Extra Strength | Winco Foods, Llc

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Family Dollar (Family Wellness)

Acetaminophen Pm Extra Strength | Perrigo New York Inc

• if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the gum on your quit day • if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule:
Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every

1 to 2 hours

1 piece every

2 to 4 hours

1 piece every

4 to 8 hours
• nicotine gum is a medicine and must be used a certain way to get the best results • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. • repeat this process until most of the tingle is gone (about 30 minutes) • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. • do not use more than 24 pieces a day • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

No Recall
Equate (Walmart Stores, Inc.)

Acetaminophen Pm Extra Strength | Powder Pharmaceuticals Inc.

Apply one Zingo™ (0.5 mg lidocaine hydrochloride monohydrate) to the site planned for venipuncture or intravenous cannulation, one to three minutes prior to needle insertion.

Perform the procedure within 10 minutes after Zingo™ administration. Use Zingo™ only on intact skin.

Application of one additional Zingo™ at a new location is acceptable after a failed attempt at venous access. Multiple administrations of Zingo™ at the same location are not recommended.

When Zingo™ is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all sources should be considered, as local anesthetics are thought to have at least additive toxicities.
2.1 Instructions for Use Prepare the Treatment Site and Device:
Examine the treatment site to ensure that the skin is intact. Clean the site, according to standard practice.

Visually inspect the pouch. Do not use if the pouch has been torn, or damaged or if the device has been dropped.

Tear open the pouch using the notch provided (Figure 1a). Remove ZingoTM   from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination (Figure 1b).

Figure 1a

Figure 1b

Position Zingo™: Grip Zingo™ and place on the application site, with one hand, as illustrated in Figure 2, or with both hands, as shown in Figure 3.

Figure 2

Figure 3

Ensure that the patient’s treatment site is supported to prevent movement. Seal the purple Zingo™ outlet against the patient’s skin. Hold the device perpendicular to the skin, making sure that your thumb can reach the green start button.

Avoid gaps between the skin and the Zingo™ outlet, like the one illustrated in Figure 4, as gaps will impede drug delivery.

Figure 4

Release the Safety Interlock: Apply adequate downward pressure to release the safety interlock, while maintaining the seal between Zingo™ and the skin.
Zingo™ is ready for administration when the green start button has moved into the upward position, as illustrated in Figure 5a.
Figure 5a

Zingo™ cannot be actuated without releasing the internal safety interlock, as illustrated in Figure 5b.
                                                                                              Figure 5b
Administer Zingo™: While maintaining downward pressure, administer the dose by pressing the green start button, as illustrated in Figure 6. Do not move Zingo™ during administration. Actuation is accompanied by a “popping” sound, indicating that the dose has been discharged.
Figure 6

Remove Zingo™: Remove Zingo™ from the application site and dispose. Begin Procedure: Start the venipuncture or intravenous cannulation procedure 1–3 minutes after Zingo™ administration. 2.1 Instructions for Use Prepare the Treatment Site and Device:
Examine the treatment site to ensure that the skin is intact. Clean the site, according to standard practice.

Visually inspect the pouch. Do not use if the pouch has been torn, or damaged or if the device has been dropped.

Tear open the pouch using the notch provided (Figure 1a). Remove ZingoTM   from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination (Figure 1b).

Figure 1a

Figure 1b

Position Zingo™: Grip Zingo™ and place on the application site, with one hand, as illustrated in Figure 2, or with both hands, as shown in Figure 3.

Figure 2

Figure 3

Ensure that the patient’s treatment site is supported to prevent movement. Seal the purple Zingo™ outlet against the patient’s skin. Hold the device perpendicular to the skin, making sure that your thumb can reach the green start button.

Avoid gaps between the skin and the Zingo™ outlet, like the one illustrated in Figure 4, as gaps will impede drug delivery.

Figure 4

Release the Safety Interlock: Apply adequate downward pressure to release the safety interlock, while maintaining the seal between Zingo™ and the skin.
Zingo™ is ready for administration when the green start button has moved into the upward position, as illustrated in Figure 5a.
Figure 5a

Zingo™ cannot be actuated without releasing the internal safety interlock, as illustrated in Figure 5b.
                                                                                              Figure 5b
Administer Zingo™: While maintaining downward pressure, administer the dose by pressing the green start button, as illustrated in Figure 6. Do not move Zingo™ during administration. Actuation is accompanied by a “popping” sound, indicating that the dose has been discharged.
Figure 6

Remove Zingo™: Remove Zingo™ from the application site and dispose. Begin Procedure: Start the venipuncture or intravenous cannulation procedure 1–3 minutes after Zingo™ administration.

No Recall
Mckesson (Health Mart)

Acetaminophen Pm Extra Strength | Mckesson (health Mart)

Directions do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours. children under 12 years: do not use

No Recall
Bjwc (Berkley & Jensen / Bj’s)

Acetaminophen Pm Extra Strength | Bjwc (berkley & Jensen / Bj's)

do not take more than directed (see overdose warning)
adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years
Do not use this adult product in children under 12 years of age, this will provide more than the recommended dose (overdose) and may cause liver damage.

No Recall
Western Family Foods Inc

Acetaminophen Pm Extra Strength | Western Family Foods Inc

• do not take more than directed (see Liver warning)
adults and children 12 years and over
• take 2 gelcaps at bedtime • do not take more than 2 gelcaps of this product in 24 hours
children under 12 years

do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Mckesson (Health Mart)

Acetaminophen Pm Extra Strength | Mckesson (health Mart)

do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours. children under 12 years: do not use

No Recall
Simply Right (Sam’s West, Inc.)

Acetaminophen Pm Extra Strength | Simply Right (sam's West, Inc.)

Directions do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use

No Recall
Equate (Walmart Stores, Inc.)

Acetaminophen Pm Extra Strength | Equate (walmart Stores, Inc.)

Directions do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use

No Recall
P And L Development Of New York Corporation (Readyincase)

Acetaminophen Pm Extra Strength | P And L Development Of New York Corporation (readyincase)

do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use

No Recall
Equaline (Supervalu)

Acetaminophen Pm Extra Strength | Equaline (supervalu)

do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours. children under 12 years: do not use

No Recall