Tylenol PM Extra Strength Acetaminophen and Diphenhydramine hydrochloride Acetaminophen Acetaminophen Diphenhydramine hydrochloride Diphenhydramine benzyl alcohol ferrosoferric oxide butylparaben carboxymethylcellulose sodium crospovidone D&C red NO. 28 edetate calcium disodium FD&C blue NO. 1 FD&C red NO. 40 gelatin hypromelloses magnesium stearate methylparaben cellulose, microcrystalline polyethylene glycols polysorbate 80 powdered cellulose propylene glycol propylparaben ferric oxide red sodium citrate sodium lauryl sulfate sodium propionate SODIUM STARCH GLYCOLATE TYPE A POTATO titanium dioxide ferric oxide yellow Light and dark blue gelcap with gray subcoat/band PM;RRG
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL See New Warnings Information & Directions NDC 50580-244-80 Extra Strength TYLENOL ® PM Pain Reliever Nighttime Sleep Aid Acetaminophen, Diphenhydramine HCl Rapid Release GELS Non-habit forming 80 RR GELCAPS Principal Display Panel
- PRINCIPAL DISPLAY PANEL See New Warnings Information & Directions NDC 50580-244-80 Extra Strength TYLENOL ® PM Pain Reliever Nighttime Sleep Aid Acetaminophen, Diphenhydramine HCl Rapid Release GELS Non-habit forming 80 RR GELCAPS Principal Display Panel
Overview
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Indications & Usage
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Dosage & Administration
Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours 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
Warnings & Precautions
Warnings 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 product Do not use 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 Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 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. If pregnant or breast-feeding, ask a health professional before use. 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 right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose
Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid
Do Not Use
Do not use 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
When Using
When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery
Stop Use & Ask a Doctor
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 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.
Keep Out of Reach of Children
Keep out of reach of children.
Storage & Handling
Other information store between 20-25°C (68-77°F). Avoid high humidity. do not use if carton is opened or neck wrap or foil inner seal imprinted with "Safety Seal®" is broken or missing see end panel for lot number and expiration date
Questions
Questions or comments? call 1-877-895-3665
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