drug facts

drug facts
SPL v2
SPL
SPL Set ID af5b9c99-03b8-4cf3-80d5-e484b36b6873
Route
oral
Published
Effective Date 2018-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (12.5 mg)
Inactive Ingredients
anhydrous citric acid d&c red no. 33 fd&c red no. 40 sodium benzoate sodium citrate saccharin sodium sorbitol sucrose water

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
otc monograph final active Since 1999-03-16
Purpose

Antihistamine

Description

Drug Facts

Medication Information

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 common cold:

  • runny nose
  • sneezing
Purpose

Antihistamine

Directions
  • take every 4-6 hours
  • Do not use more than 6 times in 24 hours
adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 to 50 mg)
children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 to 25 mg)
children under 6 years ask a doctor
Other Information
  • •
    store at room temperature 15º - 30ºC (59º - 86ºF)
  • •
    protect from freezing.
  • •
    protect from light.
  • •
    each teaspoon (5 mL) contains: sodium 16 mg
  • •
    TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
Inactive Ingredients

citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

Description

Drug Facts

Principal Display Panel

Section 42229-5

Drug Facts

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
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 machiney
  • 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.

Ask A Doctor Before Use If You Have
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis.
  • a sodium-restricted diet
Active Ingredient in Each 5 Ml ( in One Teaspoonful)

Diphenhydramine HCl, USP HCl 12.5 mg.

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 common cold:

  • runny nose
  • sneezing
Purpose

Antihistamine

Directions
  • take every 4-6 hours
  • Do not use more than 6 times in 24 hours
adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 to 50 mg)
children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 to 25 mg)
children under 6 years ask a doctor
Other Information (Other information)
  • •
    store at room temperature 15º - 30ºC (59º - 86ºF)
  • •
    protect from freezing.
  • •
    protect from light.
  • •
    each teaspoon (5 mL) contains: sodium 16 mg
  • •
    TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
Inactive Ingredients (Inactive ingredients)

citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Section 42229-5 (42229-5)

Drug Facts

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
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 machiney
  • 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis.
  • a sodium-restricted diet
Active Ingredient in Each 5 Ml ( in One Teaspoonful) (Active ingredient in each 5 mL ( in one teaspoonful))

Diphenhydramine HCl, USP HCl 12.5 mg.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:33.687111 · Updated: 2026-03-14T22:55:06.338046