Allergy and Headache ACETAMINOPHEN DIPHENHYDRAMINE HCL CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED FDA Approved Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes minor aches and pains headache itching of the nose or throat
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 325 mg Diphenhydramine HCl 25 mg
Inactive Ingredients
Inactive ingredients corn starch croscarmellose sodium crospovidone FD&C blue #1 aluminum lake hypromellose magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol povidone K30 pregelatinized starch silicon dioxide stearic acid titanium dioxide triacetin
Strengths
325 mg 25 mg
Quantities
18615 count
Treats Conditions
Uses Temporarily Relieves These Symptoms Of Hay Fever Or Other Upper Respiratory Allergies Runny Nose Sneezing Itchy Watery Eyes Minor Aches And Pains Headache Itching Of The Nose Or Throat
Pill Appearance
Shape: oval Color: blue Imprint: 44;516

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D TC2D6JAD40
Packaging

Principal display panel ♥︎ CVS ™ NDC 51316-561-09 actual size Maximum Strength † ALLERGY & HEADACHE Acetaminophen , Pain Reliever Diphenhydramine HCl, Antihistamine 20 CAPLETS Relief of: Headache, Sneezing, Runny nose, Itchy throat & Itchy, watery eyes † Under OTC monograph. TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 ORG072551609 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-18615 100% money back guaranteed. CVS.com/returnpolicy CVS 44-516 CVS 44-516

Package Descriptions
  • Principal display panel ♥︎ CVS ™ NDC 51316-561-09 actual size Maximum Strength † ALLERGY & HEADACHE Acetaminophen , Pain Reliever Diphenhydramine HCl, Antihistamine 20 CAPLETS Relief of: Headache, Sneezing, Runny nose, Itchy throat & Itchy, watery eyes † Under OTC monograph. TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 ORG072551609 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-18615 100% money back guaranteed. CVS.com/returnpolicy CVS 44-516 CVS 44-516

Overview

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes minor aches and pains headache itching of the nose or throat

Indications & Usage

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes minor aches and pains headache itching of the nose or throat

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

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 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 Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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 Antihistamine

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

When Using

When using this product excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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 TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN see end flap for expiration date and lot number store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Questions

Questions or comments? 1-800-426-9391


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →