FDA records indicate that there are no current recalls for this drug.
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Headache Formula 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 4,000 mg of acetaminophen in 24 hours
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with other drugs containing acetaminophen
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3 or more alcoholic drinks every day while using this product
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with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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with any other product containin diphenhydramine, even one used on skin
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in children under 12 years of age
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a breathing problem such as emphysema or chronic bronchitis
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liver disease
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trouble urinating due to an enlarged prostate gland
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glaucoma
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taking sedatives or tranquilizers
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taking the blood thinning drug warfarin
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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
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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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
-
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 containin diphenhydramine, even one used on skin
-
in children under 12 years of age
-
a breathing problem such as emphysema or chronic bronchitis
-
liver disease
-
trouble urinating due to an enlarged prostate gland
-
glaucoma
-
taking sedatives or tranquilizers
-
taking the blood thinning drug warfarin
-
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
Headache Formula Pm Manufacturers
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Supervalu Inc.
Headache Formula Pm | Supervalu Inc.
do not take more than directed
(see overdose warning)adults and children 12 years and over: take 2 tablets at bedtime. Do not take more than 2 tablets 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.
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