RxNorm Names
SILADRYL ALLERGY MEDICINE
(diphenhydramine hydrochloride)
liquid
[Silarx Pharmaceuticals, Inc]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1cee4078-fe92-4af2-a2dd-bde4e9ccdfbd| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
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
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
- a sodium restricted diet
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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- repeat dose every 4 to 6 hours
- do not take more than 6 doses in any 24-hour period
- Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
| adults and children 12 years and over | 2 to 4 teaspoonfuls (TSP) |
| children 6 to under 12 years | 1 to 2 teaspoonfuls (TSP) |
| children under 6 years | DO NOT USE |
Each 5 mL (1 TSP) contains: Sodium 14 mg. 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.
| SILADRYL ALLERGY MEDICINE
diphenhydramine hydrochloride liquid |
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| Labeler - Silarx Pharmaceuticals, Inc (161630033) |
Revised: 12/2012
Document Id: b27019cb-a4b6-46f2-b67e-2be2ca0c8424
Set id: 1cee4078-fe92-4af2-a2dd-bde4e9ccdfbd
Version: 11
Effective Time: 20121227
Silarx Pharmaceuticals, Inc
Review RxNorm Normal Forms