The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active ingredients (in each caplet) Acetaminophen 500 mgDiphenhydramine HCl 25 mg
Otc - Purpose
PurposePain relieverNighttime sleep-aid
Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Liver warning: This product contains acetaminophen. 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 productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
Otc - Do Not Use
Do not use■ with any other product containing diphenhydramine, even one used on skin■ in children under 12 years of age■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.■ if you have ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor
Ask a doctor before use if you have■ liver disease■ a breathing problem such as emphysema or chronic bronchitis■ difculty in urination due to enlargement of the prostate gland■ glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are■ taking the blood thinning drug warfarin■ taking sedatives or tranquilizers
Otc - When Using
When using this product■ avoid alcoholic beverages■ do not drive a motor vehicle or operate machinery■ drowsiness will occur
Otc - Stop Use
Stop use and ask a doctor if■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. ■ new symptoms occur■ redness or swelling is present■ pain gets worse or lasts more than 10 days■ fever gets worse or lasts more than 3 daysThese could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: 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.
■ do not take more than directed (see overdose warning)■
adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. ■
children under 12 years: do not use
■ store at room temperature
Croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide and triacetin
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGDistributed by:MAJOR® PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233Livonia, MI 48152
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