FDA records indicate that there are no current recalls for this drug.
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Aspirin Free Headache Pm Recall
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Questions & Answers
Side Effects & Adverse Reactions
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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more than 2 tablets in 24 hours, which is the maximum daily amount
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with other drugs containing acetaminophen
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3 or more alcoholic drinks every day while using this product
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
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drowsiness may occur
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avoid alcoholic beverages
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be careful when driving a motor vehicle or operating machinery
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sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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pain gets worse or lasts more than 10 days
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fever gets worse or lasts more than 3 days
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new symptoms occur
-
painful area is red or swollen
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
-
sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
-
pain gets worse or lasts more than 10 days
-
fever gets worse or lasts more than 3 days
-
new symptoms occur
-
painful area is red or swollen
These could be signs of a serious condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Aspirin Free Headache Pm Manufacturers
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Greenbrier International, Inc.
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