FDA Label for Diphenhydramine Oral Solution
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML-TEASPOONFUL)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- 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
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTION OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Diphenhydramine Oral Solution Product Label
The following document was submitted to the FDA by the labeler of this product Aldama Pharmaceuticals, Inc. 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.
Active Ingredient (In Each 5 Ml-Teaspoonful)
Diphenhydramine KCI 12.5mg
Purpose
Antihistamine
Uses
- Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- itchy nose or throat
- sneezing
- itchy, watery eyes
- runny nose
- sneezing
Temporarily relieves these symptoms due to the common cold
Warnings
Do not use
with any other drug containing diphenhydramine, including one used on the skin.
to make a child sleepy
Do Not Use
- with any other drug containing diphenhydramine, including one used on the skin.
- to make a child sleepy
Ask A Doctor Before Use If You Have
- a breathing problem such as chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving motor vehicle or operating machinery
- avoid alcoholic drinks
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.
Directions
- Take every 4 hours, as needed, or as directed by a doctor
- Do not take more than 6 doses in 24 hours
- adults and children 12 years and over: 10 to 20 ml 2 to 4 teaspoonsful
- Children under 12 years: consult a doctor
Other Information
- TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing
- store at room temperature between 15-30°C (59-86°F)
- do not freeze
- protect from light
- Pharmacist: For dispensing, use a light-resistent container with a child-resistant cap
Inactive Ingredient
artificial and natural cherry flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Question Or Comments?
305-592-9216 or [email protected]
* Please review the disclaimer below.