ASPIRIN FREE HEADACHE PM- acetaminophen and diphenhydramine citrate tablet
GREENBRIER INTERNATIONAL, INC.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Assured 44-373
Uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
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
Do not use
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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
Ask a doctor before use if
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a breathing problem such as emphysema or chronic bronchitis
-
liver disease
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trouble urinating due to an enlarged prostate gland
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glaucoma
Ask a doctor or pharmacist before use if
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taking sedatives or tranquilizers
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taking the blood thinning drug warfarin
When using this product
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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
Stop use and ask a doctor if
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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.
Keep out of reach of children.
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.
Directions
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do not take more than directed (see overdose warning)
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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.
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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.
Other information
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store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
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see end flap for expiration date and lot number
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide
Principal Display Panel
ASSURED™
*COMPARE TO THE ACTIVE INGREDIENT IN EXCEDRIN® PM
Aspirin Free
HEADACHE PM
Acetaminophen 500 mg /
Diphenhydramine citrate 38 mg
Pain Reliever/Nighttime Sleep-Aid
Non-habit forming
20 tablets
*This product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® PM.
50844 ORG071237309
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Assured 44-373
| ASPIRIN FREE HEADACHE PM
acetaminophen and diphenhydramine citrate tablet |
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| Labeler - GREENBRIER INTERNATIONAL, INC. (610322518) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(33992-0373) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(33992-0373) | |