FDA Label for Diphenhydramine Hydrochloride

View Indications, Usage & Precautions

OTC - ACTIVE INGREDIENT
USES
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
WHEN USING THIS PRODUCT
IF PREGNANT OR BREAST-FEEDING,
DIRECTIONS
INACTIVE INGREDIENTS
OTHER INFORMATION
OTC - KEEP OUT OF REACH OF CHILDREN
OVERDOSAGE
QUESTIONS?
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Oncor Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient

Active ingredients (in each 5 mL teaspoonful) Purpose

Diphenhydramine Hydrochloride 12.5mg .............................Antihistamine

Uses

- sneezing

- runny nose

- itchy, watery eyes

- itching of the nose or throat

- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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.

Directions

- take every 4 to 6 hours or as directed by a doctor

- do not take more then directed

- mL=milliliter

- find right dose on chart below


Children under 2 years	Do not use
Children 2 to 5 years	Ask a doctor
Children 6 to 11 years	1-2 teaspoonful
Adults and children 12 years and over	2-4 teaspoonful

Inactive Ingredients

citric acid, flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.

Other Information

- each 1 tsp (5mL) contains: sodium 4 mg

- store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]. Protect from freezing.

- tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Questions?

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Principal Display Panel

Oncor Pharmaceuticals

NDC 83720-502-16

Diphenhydramine Hydrochloride
Oral Solution

12.5 mg/5 ml

Antihistamine

Cherry Flavor

RELIEVES

- Sneezing

- Itchy, Watery Eyes

- Runny Nose

- Itchy Throat due to Allergies

DO NOT USE IF TAMPER EVIDENT SEAL
UNDER CAP IS BROKEN OR MISSING

Alcohol Free

NET WT. 16 fl OZ. (473 ml)

NDC 83720-502-08