Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE K30 STARCH, CORN SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE TALC ALUMINUM OXIDE CARNAUBA WAX POLYSORBATE 80 WATER S525;P525;G651
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel Compare to the active ingredients in Extra Strength TYLENOL® PM† Extra Strength Pain Reliever PM pain reliever/nighttime sleep-aid Acetaminophen 500 mg diphenhydramine HCl 25 mg non-habit forming †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: PL Developments 200 Hicks Street Westbury, NY 11590; Product Label READYinCASE Extra Strength Pain Reliever PM Acetaminophen 500 mg, Diphenhydramine HCI 25 mg
- Principal Display Panel Compare to the active ingredients in Extra Strength TYLENOL® PM† Extra Strength Pain Reliever PM pain reliever/nighttime sleep-aid Acetaminophen 500 mg diphenhydramine HCl 25 mg non-habit forming †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: PL Developments 200 Hicks Street Westbury, NY 11590
- Product Label READYinCASE Extra Strength Pain Reliever PM Acetaminophen 500 mg, Diphenhydramine HCI 25 mg
Overview
Uses temporary relief of occasional headaches and minor aches and pains accompanying sleeplessness
Indications & Usage
Uses temporary relief of occasional headaches and minor aches and pains accompanying sleeplessness
Dosage & Administration
Directions 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
Warnings & Precautions
Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take: more than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may incluse: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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 other products 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 care professional before use. 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. Directions 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 Other information store between 15- 30 o C (59- 86 o F) avoid high humidity and excessive heat
Purpose
Purpose Pain reliever 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 other products 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. 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.
Questions
Questions or comments? Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST
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