HYDRAMINE - diphenhydramine hydrochloride liquid
Goldline Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each teaspoon (5 mL))

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

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

Warnings

Do not use

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

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

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

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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years and over	2 to 4 teaspoons (25 mg to 50 mg)
children 6 to under 12 years	ask a doctor
children 4 to 5 years	do not use unless directed by a doctor
children under 4 years	do not use

Other information

each teaspoon (5 mL) contains: sodium 5 mg
store between 20°-25°C (68°-77°F). Protect from light.

Inactive ingredients

artificial cherry flavors, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

HYDRAMINE
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0182-6168
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE	12.5 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
FD&C RED NO. 40
GLYCERIN
POLYSORBATE 20
WATER
SODIUM BENZOATE
SODIUM CITRATE
SACCHARIN SODIUM DIHYDRATE
SORBITOL

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0182-6168-40	473 mL in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/01/1994	09/30/2011

Labeler - Goldline Laboratories, Inc. (032349292)

Revised: 09/2012 Goldline Laboratories, Inc.