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Allergy and Headache

Dosage form
TABLET, FILM COATED
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Label updated
2025-11-07
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Active ingredients (in each caplet)

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Antihistamine

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
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.

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
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)
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

Questions or comments?

1-800-426-9391

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

[Image in the official label — see DailyMed source]

 

DailyMed Set ID: dc249163-26dd-42ca-b423-2f16299f2d65 · Version 2
NDC: 51316-561