FDA Label for Allergy Relief
View Indications, Usage & Precautions
Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceuticals International Division. 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 ingredient (in each 5 mL teaspoonful)
Diphenhydramine HCl 12.5 mg
Otc - Purpose
Purpose
Antihistamine
Indications & Usage
Uses
- Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- itchy nose or throat
- sneezing
- itchy, watery eyes
- Temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
Warnings
Warnings
Do not use
- with any other product conatining diphenhydramine, including one used on the skin
- to make a child sleepy
- a breathing problem such as chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- glaucoma
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving motor vehicle or operating machinery
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
Dosage & Administration
Directions
- do not exceed recommended dose
- take every 4 to 6 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 teaspoonful)
- children under 12 years: consult a doctor
Inactive Ingredient
Inactive ingredients: Artificial and natural cherry flavor, citric acid, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose and sucrose.
Otc - Questions
Questions or comments? 1-800-540-3765
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