Headache Relief Extra Strength

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Headache Relief Extra Strength Recall

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Side Effects & Adverse Reactions

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

asthma (wheezing)
facial swelling
shock
hives

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

more than 8 caplets in 24 hours, which is the maximum daily amount
3 or more alcoholic drinks every day while using this product
with other drugs containing acetaminophen

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
take more or for a longer time than directed
have 3 or more alcoholic drinks every day while using this product

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

you have liver disease
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you are taking a diuretic
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis
taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
any new symptoms appear
ringing in the ears or loss of hearing occurs
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
painful area is red or swollen

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

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

if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

you have liver disease
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you are taking a diuretic
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis
taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
any new symptoms appear
ringing in the ears or loss of hearing occurs
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
painful area is red or swollen

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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

temporarily relieves minor aches and pains due to:
- a cold
- arthritis
- headache
- muscular aches
- sinusitis
- toothache
- premenstrual and menstrual cramps

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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

Headache Relief Extra Strength Manufacturers

L.n.k. International, Inc.

Headache Relief Extra Strength | L.n.k. International, Inc.

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over take 2 caplets every 6 hours do not take more than 8 caplets in 24 hours children under 12 years: ask a doctor

No Recall
Meijer

Headache Relief Extra Strength | Meijer

do not use more than directed

drink a full glass of water with each dose

adults and children 12 years and over

take 2 caplets every 6 hours

do not take more than 8 caplets in 24 hours

children under 12 years: ask a doctor

No Recall
Smart Sense (Kmart)

Headache Relief Extra Strength | Smart Sense (kmart)

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Winco Foods, Llc

Headache Relief Extra Strength | Liddell Laboratories, Inc.

Adults and children over 12: Spray twice under the tongue up to 6 times per day until symptoms are relieved.

Children 12 and under: Consult a doctor prior to use.

No Recall
Wal-mart Stores Inc

Headache Relief Extra Strength | Wal-mart Stores Inc

do not use more than directed

drink a full glass of water with each dose

adults and children 12 years and over

take 2 caplets every 6 hours

do not take more than 8 caplets in 24 hours

children under 12 years: ask a doctor

No Recall
Western Family Foods, Inc.

Headache Relief Extra Strength | Western Family Foods, Inc.

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor Other information store at controlled room temperature 200 - 250 C (680 - 770 F) excursions permitted to 15o C to 30o C (59o -86o F) do not use if imprinted safety seal under cap is broken or missing **this product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® Extra Strength

No Recall
Amerisource Bergen

Headache Relief Extra Strength | Amerisource Bergen

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor Other information store at controlled room temperature 200 - 250 C (680 - 770 F) excursions permitted to 15o C to 30o C (59o -86o F) do not use if imprinted safety seal under cap is broken or missing **this product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® Extra Strength

No Recall
Geiss, Destin & Dunn, Inc (Goodsense)

Headache Relief Extra Strength | Geiss, Destin & Dunn, Inc (goodsense)

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor Other information store at controlled room temperature 200 - 250 C (680 - 770 F) excursions permitted to 15o C to 30o C (59o -86o F) **This product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® Extra Strength

No Recall
Hy-vee

Headache Relief Extra Strength | Hy-vee

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor Other information store at controlled room temperature 200 - 250 C (680 - 770 F) excursions permitted to 15o C to 30o C (59o -86o F)

No Recall
Publix Supermarkets, Inc.

Headache Relief Extra Strength | Publix Supermarkets, Inc.

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor

No Recall
Smart Sense (Kmart)

Headache Relief Extra Strength | Smart Sense (kmart)

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor

No Recall
Dolgencorp, Inc. (Dollar General & Rexall)

Headache Relief Extra Strength | Dolgencorp, Inc. (dollar General & Rexall)

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor

No Recall
Good Sense (Geiss, Destin & Dunn, Inc.)

Headache Relief Extra Strength | Good Sense (geiss, Destin & Dunn, Inc.)

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Dolgencorp, Inc. (Dollar General & Rexall)

Headache Relief Extra Strength | Dolgencorp, Inc. (dollar General & Rexall)

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Western Family Foods, Inc.

Headache Relief Extra Strength | Western Family Foods, Inc.

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Amerisourcebergen (Good Neighbor Pharmacy) 46122

Headache Relief Extra Strength | Amerisourcebergen (good Neighbor Pharmacy) 46122

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Hy-vee

Headache Relief Extra Strength | Hy-vee

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Top Care (Topco Associates Llc)

Headache Relief Extra Strength | Top Care (topco Associates Llc)

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Meijer, Inc.

Headache Relief Extra Strength | Meijer, Inc.

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

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

Headache Relief Extra Strength | P And L Development Of New York Corporation (readyincase)

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Publix Supermarkets, Inc.

Headache Relief Extra Strength | Publix Supermarkets, Inc.

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Family Dollar (Family Wellness)

Headache Relief Extra Strength | Family Dollar (family Wellness)

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Wal-mart Stores Inc

Headache Relief Extra Strength | Wal-mart Stores Inc

do not use more than directed

drink a full glass of water with each dose

adults and children 12 years and over

take 2 caplets every 6 hours

do not take more than 8 caplets in 24 hours

children under 12 years: ask a doctor

No Recall
Walgreens

Headache Relief Extra Strength | Walgreens

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Cvs Pharmacy

Headache Relief Extra Strength | Cvs Pharmacy

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

No Recall
Woonsocket Prescription Center,incorporated

Headache Relief Extra Strength | Fresh Inc.

Apply to underarms only

No Recall