Cvs Diphenhydramine Hydrochloride

Cvs Diphenhydramine Hydrochloride
SPL v2
SPL
SPL Set ID 3d71d306-893a-e73a-e063-6394a90a0a3b
Route
ORAL
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate D&c Red No. 27 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S4 Shape: capsule Color: pink Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01
Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat 

• temporarily relieves these symptoms due to the common cold: • runny nose • sneezing

Warnings

Directions
  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 adults and children 12 years and over  1 to 2 tablets
 children 6 to under 12 years  1 tablet
 children under 6 years  do not use

Do Not Use

• to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

Drug Facts

Other Information
  • store between 20°–25°C (68°–77°F)
  • protect from moisture and light
Package Labeling:

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red #27 Al lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

Questions Or Comments?

Call 1-800-SHOP CVS

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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. (1-800-222-1222)

Active Ingredient (in Each Tablet)

Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have

• a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You
  • are taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat 

• temporarily relieves these symptoms due to the common cold: • runny nose • sneezing

Purpose

Antihistamine

Warnings

Directions
  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 adults and children 12 years and over  1 to 2 tablets
 children 6 to under 12 years  1 tablet
 children under 6 years  do not use

Do Not Use (Do not use)

• to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

Drug Facts

Other Information (Other information)
  • store between 20°–25°C (68°–77°F)
  • protect from moisture and light
Package Labeling:

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red #27 Al lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

Questions Or Comments? (Questions or comments?)

Call 1-800-SHOP CVS

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

 ask a health professional before use

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. (1-800-222-1222)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)
  • are taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:00.424979 · Updated: 2026-03-14T23:12:06.957806