DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Citric Acid Monohydrate D&c Red No. 33 Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Poloxamer 407 Water Sodium Benzoate Sodium Chloride Sodium Citrate Sorbitol

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH FINAL Active Since 2006-06-29

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

Uses

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

Directions

if needed, take every 4-6 hours
do not take more than 6 doses in 24 hours

children under 4 years of age	do not use
children 4 to under 6 years of age	do not use unless directed by a doctor
children 6 to under 12 years of age	1 to 2 teaspoonfuls (12.5 mg to 25 mg)
adults and children 12 years of age and over	2 to 4 teaspoonfuls (25 mg to 50 mg)

Do Not Use

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

Other Information

each teaspoonful contains: sodium 15 mg
store at 20°-25°C (68°-77°F)

Inactive Ingredients

citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

Questions Or Comments?

1-800-719-9260

Principal Display Panel

Diphenhydramine Hydrochloride

12.5 mg/ 5 mL

NDC 54868-5622-0

Relieves:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

See New Warning and Dosing Directions

Cherry Flavored

4 fl oz (118 mL)

Alcohol Free

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

When Using This Product

avoid alcoholic drinks
marked drowsiness may occur
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

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

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
a sodium-restricted diet

Active Ingredient (in Each 5 Ml Teaspoonful)

Diphenhydramine HCl 12.5 mg

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:
sneezing
itching of the nose or throat
runny nose
itchy, watery eyes
temporarily relieves these symptoms due to the common cold:
sneezing
runny nose

Purpose

Antihistamine

Directions

if needed, take every 4-6 hours
do not take more than 6 doses in 24 hours

children under 4 years of age	do not use
children 4 to under 6 years of age	do not use unless directed by a doctor
children 6 to under 12 years of age	1 to 2 teaspoonfuls (12.5 mg to 25 mg)
adults and children 12 years of age and over	2 to 4 teaspoonfuls (25 mg to 50 mg)

Do Not Use (Do not use)

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

Other Information (Other information)

each teaspoonful contains: sodium 15 mg
store at 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

Diphenhydramine Hydrochloride

12.5 mg/ 5 mL

NDC 54868-5622-0

Relieves:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

See New Warning and Dosing Directions

Cherry Flavored

4 fl oz (118 mL)

Alcohol Free

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

When Using This Product (When using this product)

avoid alcoholic drinks
marked drowsiness may occur
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

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)

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
a sodium-restricted diet

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Diphenhydramine HCl 12.5 mg

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

taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itching of the nose or throat runny nose itchy, watery eyes temporarily relieves these symptoms due to the common cold: sneezing runny nose", "Purpose": "Antihistamine", "Directions": "if needed, take every 4-6 hours do not take more than 6 doses in 24 hours children under 4 years of age do not use children 4 to under 6 years of age do not use unless directed by a doctor children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 mg to 25 mg) adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 mg to 50 mg)", "Do not use": "with any other product containing diphenhydramine, even one used on skin to make a child sleepy", "Other information": "each teaspoonful contains: sodium 15 mg store at 20°-25°C (68°-77°F)", "Inactive ingredients": "citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol", "Questions or comments?": "1-800-719-9260", "Principal Display Panel": "Diphenhydramine Hydrochloride 12.5 mg/ 5 mL NDC 54868-5622-0 Relieves: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat See New Warning and Dosing Directions Cherry Flavored 4 fl oz (118 mL) Alcohol Free Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146", "When using this product": "avoid alcoholic drinks marked drowsiness may occur excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery", "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": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland a sodium-restricted diet", "Active ingredient (in each 5 mL teaspoonful)": "Diphenhydramine HCl 12.5 mg", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information