FDA Label for Diphenhydramine Hcl Strawberry Flavor
View Indications, Usage & Precautions
Diphenhydramine Hcl Strawberry Flavor Product Label
The following document was submitted to the FDA by the labeler of this product Innovida Pharmaeutique Corporation. 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 5Ml Tsp)
Diphenhydramine HCl, 12.5 mg
Purpose
Antihistamine
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to the enlarged prostate gland
- excitability might occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness effect
- be careful when driving a motor vehicle or operating machinery
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are takingsedatives or tranquilizers
When using this product:
If pregnant of 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 (1-800-222-1222) right away.
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
- runny nose
- sneezing
Temporarily relieves these symptoms due to the common cold:
Directions
- Take every 4 to 6 hours, or as directed by a doctor.
- Do not exceed recommended dose.
| Adults and Children 12 years of age and over | take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours |
Children 6 to under 12 years of age Children under 6 years of age: | take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours consult a doctor |
Other Information
- Store at controlled room temperature 15° - 30°C (59° - 86°F).
- Do not refrigerate. Avoid excessive heat or humidity.
- Protect from light.
Inactive Ingredients
Citric acid, FD&C red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, strawberry flavor, sucralose.
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Product Label
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