ACETAMINOPHEN DIPHENHYDRAMINE HCL- acetaminophen diphenhydramine hcl tablet
Granules USA, 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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temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
This product containsacetaminophen. 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
acetaminophen may cause severs skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away
■ 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
■ if you have ever had an allergic reaction to this product or any of its ingredients
■ liver disease
■ a breathing problem such as emphysema or chronic brochitis
■ trouble urinating due to an enlarged prostate gland
■ glaucoma
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
■ drowsiness will occur
■ avoid alcoholic drinks
■ do not drive a motor vehicle or operate machinery
■ sleeplessness persists continuously for morethan 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
■ pain gets worse or lasts more t han 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
These could be signs of a serious condition.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ do not take more than directed (see overdose warning)
adults andchildren 12 years and over
■ take 2 caplets at bedtime do not use
■ do not take more than 2 caplets of this product in 24 hours
children under 12 years
■ do not use
■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
■ see end panel for expiration date and lot number
ACETAMINOPHEN DIPHENHYDRAMINE HCL
acetaminophen diphenhydramine hcl tablet |
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Labeler - Granules USA, Inc. (137098864) |