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.
Distributed by: MAJOR® PHARMACEUTICALS17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152*This product is not manufactured or distributed by McNeil Consumer Products Co., owner of the registered trademark Tylenol®.Do not use if carton is open, or if imprinted safety seal under cap is broken or missing.
Otc - Active Ingredient
Active ingredients (in each caplet)Acetaminophen 500 mg
Diphenhydramine HCl 25mg
Otc - Purpose
Nighttime Sleep Aid
Indications & Usage
Uses Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
- WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- More than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddeningblisters rashIf a skin reaction occurs, stop use and seek medical help right away.
Otc - Do Not Use
- Do not usewith any other drug 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 agewith any other product containing diphenhydramine, even one used on skinif 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 haveliver diseasea breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandglaucoma
Otc - Ask Doctor/Pharmacist
- Aska doctor or pharmacist before use if you aretaking the blood thinning drug warfarintaking sedatives or tranquilizers
Otc - When Using
- When using this productdrowsiness will occuravoid alcoholic drinksdo not drive a motor vehicle or operate machinery
Otc - Stop Use
- Stop use and ask a doctor ifsleeplessness persists 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 daysfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese 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.
Warnings And Precautions
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical help is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
- Directionsdo 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
Storage And Handling
- Other informationStore at room temperature
Inactive ingredients Croscarmellose sodium, crospovidone, FD&C blue #1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silica, sodium starch glycolate, stearic acid, titanium dioxide
Otc - Questions
Questions or comments? Call (800) 616-2471
* Please review the disclaimer below.