Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 FD&C RED NO. 3 GELATIN HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL STEARIC ACID TITANIUM DIOXIDE AMMONIA FERRIC OXIDE RED STARCH, CORN SHELLAC dark blue light blue L;6
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel CVS Health ™ Compare to the active ingredients in Extra Strength Tylenol ® PM* Gelcaps NDC 59779-556-13 EXTRA STRENGTH Pain Relief PM ACETAMINOPHEN, 500 mg DIPHENHYDRAMINE HCl, 25 mg Pain reliever, Nighttime sleep aid Non-habit forming Actual Size RAPID RELEASE 250 GELCAPS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol ® PM. 50844 ORG061555613 Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895 © 2017 CVS/pharmacy CVS.com ® 1-800-SHOP CVS V-11112 CVS 44-556 CVS 44-556
- Principal Display Panel CVS Health ™ Compare to the active ingredients in Extra Strength Tylenol ® PM* Gelcaps NDC 59779-556-13 EXTRA STRENGTH Pain Relief PM ACETAMINOPHEN, 500 mg DIPHENHYDRAMINE HCl, 25 mg Pain reliever, Nighttime sleep aid Non-habit forming Actual Size RAPID RELEASE 250 GELCAPS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol ® PM. 50844 ORG061555613 Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895 © 2017 CVS/pharmacy CVS.com ® 1-800-SHOP CVS V-11112 CVS 44-556 CVS 44-556
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 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
Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 3 or more alcoholic drinks every day while using this product Allergy 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. 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 if you are allergic to acetaminophen or any of the inactive ingredients in this product in children under 12 years of age Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the 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 beverages do not drive a motor vehicle or operate machinery Stop use and ask a doctor if pain gets worse or lasts more than 10 days 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 fever gets worse or lasts more than 3 days 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. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 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 if you are allergic to acetaminophen or any of the inactive ingredients in this product in children under 12 years of age
When Using
When using this product drowsiness will occur avoid alcoholic beverages do not drive a motor vehicle or operate machinery
Stop Use & Ask a Doctor
Stop use and ask a doctor if pain gets worse or lasts more than 10 days 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 fever gets worse or lasts more than 3 days These could be signs of a serious condition.
Keep Out of Reach of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 avoid high humidity store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
Questions
Questions or comments? 1-800-426-9391
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