Headache PM Aspirin Free Acetaminophen and Diphenhydramine Citrate ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYSORBATE 80 POVIDONE STEARIC ACID TITANIUM DIOXIDE 44;373
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel ASSURED™ *COMPARE TO ACTIVE INGREDIENTS OF EXCEDRIN® PM* ASPIRIN FREE Headache PM • Acetaminophen 500 mg Pain Reliever • Diphenhydramine Citrate 38 mg Nighttime Sleep-Aid Actual Size NON HABIT FORMING 20 tablets TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® PM. 50844 REV0414B37309 ITEM# 194143 DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY CHESAPEAKE, VA 23320 Assured 44-373 Assured 44-373
- Principal Display Panel ASSURED™ *COMPARE TO ACTIVE INGREDIENTS OF EXCEDRIN® PM* ASPIRIN FREE Headache PM • Acetaminophen 500 mg Pain Reliever • Diphenhydramine Citrate 38 mg Nighttime Sleep-Aid Actual Size NON HABIT FORMING 20 tablets TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® PM. 50844 REV0414B37309 ITEM# 194143 DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY CHESAPEAKE, VA 23320 Assured 44-373 Assured 44-373
Overview
Uses for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Indications & Usage
Uses for the 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 of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor 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 2 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use if you are allergic to acetaminophen with 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 age with any other product containing diphenhydramine, even one used on skin 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 may occur avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness lasts 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 days fever gets worse or lasts more than 3 days new symptoms occur painful area is red or swollen 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 (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.
Purpose
Purpose Pain reliever Nighttime sleep-aid
Do Not Use
Do not use if you are allergic to acetaminophen with 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 age with any other product containing diphenhydramine, even one used on skin
When Using
When using this product drowsiness may occur avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery
Stop Use & Ask a Doctor
Stop use and ask a doctor if sleeplessness lasts 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 days fever gets worse or lasts more than 3 days new symptoms occur painful area is red or swollen These could be signs of a serious condition.
Keep Out of Reach of Children
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 (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.
Storage & Handling
Other information store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Questions
Questions or comments? 1-800-426-9391
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