New World Imports, Inc
Acetaminophen 500 mg
Diphenhydramine HCI 25 mg
Acetaminophen - Pain Reliever
Diphenhydramine - Nighttime Sleep Aid
Keep out of reach of Children
Temporary relief of occasional headaches, minor aches, and pains accompanying sleeplessness
Liver Warning:This product contains acetaminophen. Severe liver damage may occur with this product if you take:
More than 2 caplets in 24 hours, which is the daily maximum amount
With other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Overdose warning: Taking more than the recommended done (overdose) may cause liver damage. 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 children even if you do not notice any signs or symptoms.
Do not use:
With other products 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 other products containing diphenhydramine, even one used on skin
Ask a doctor before use if you have: liver disease, asthma, breathing problems such as emphysema or chronic bronchitis, glaucoma, or difficulty in urinating due to an enlargement of the prostate gland.
Ask a doctor or pharmacist before use if you are: taking sedatives or tranquilzers, or taking the blood thinning drug warfin
When using this product: Avoid alcoholic beverages, do not drive a motor vehicle or operate machinery. This product will cause drowsiness.
Stop use and ask a doctor if:
Sleepiness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
Pain gets worse or last for more than 10 days
Fever gets worse or lasts for more than 3 days
New symptoms occur
Redness or swelling is present
If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children.
Do not exceed recommended dose
Adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours.
Children under 12 years of age:Do not use this product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage.
FD and C Blue #1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyvinyl alcohol, polyvinylpyrrolidone, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide.
diphenhydramine, acetaminophen tablet
|Application Number or Monograph Citation
|Marketing Start Date
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|OTC monograph final
|Labeler - New World Imports, Inc (075372276)