FDA Label for Siladryl Allergy Medicine
View Indications, Usage & Precautions
Siladryl Allergy Medicine Product Label
The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. 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: Diphenhydramine HCl 12.5 mg (in each 5 mL*)
* 5 mL = 1 teaspoonful
Otc - Purpose
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
- runny nose
- temporarily relieves these symptoms due to common cold:
- runny nose
- sneezing
- runny nose
Warnings
Do not use with any other product containing diphenhydramine, including one applied topically.
Otc - Ask Doctor
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
- a sodium restricted diet
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
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
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.
Directions
- repeat dose every 4 to 6 hours
- do not take more than 6 doses in any 24-hour period
| adults and children 12 years and over | 2 to 4 teaspoonfuls |
| children 6 to under 12 years | 1 to 2 teaspoonfuls |
| children under 6 years | DO NOT USE |
Other information
Store at room temperature 20°-25°C (68°-77°F).
Inactive Ingredients
citric acid, D&C red no. 33, FD&C red no. 40, black cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol, water.
Other
Questions
888-974-5279
† This product is not manufactured or distributed by Warner-Lambert Consumer Healthcare, owner of the registered trademark Benadryl®.
Manufactured by:
Silarx Pharmaceuticals, Inc.
19 West Street
Spring Valley, NY 10977
USA
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
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* Please review the disclaimer below.