RxNorm Names
SILPHEN
(diphenhydramine hydrochloride)
syrup
[Silarx Pharmaceutical, Inc]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d18e22f2-8cda-4862-b437-e83648a5108a| 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.
Warnings
Do not use with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough is accompanied by excessive phlegm (mucus)
- breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor
if symptoms last for more than 1 week or recurred or accompanied by fever, rash, headache
When using this product
- you may get drowsy
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
If pregnant or breast-feeding
- ask a health professional before use.
Keep out of reach of children.
-
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Do not take more than six doses
| Adults and children over 12 years | 2 teaspoonfuls (TSP) every 4 hours |
| children under 12 years | DO NOT USE |
Inactive ingredients:
Alcohol 5%, ammonium chloride, citric acid, D&C red no. 33, FD&C red no. 40, menthol, methylparaben, propylene glycol, propylparaben, sodium citrate, strawberry flavor, sucrose, water
| SILPHEN
diphenhydramine hydrochloride syrup |
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| Labeler - Silarx Pharmaceutical, Inc (161630033) |
Revised: 12/2012
Document Id: 3ab79984-0a72-48bf-beaf-35e109529196
Set id: d18e22f2-8cda-4862-b437-e83648a5108a
Version: 14
Effective Time: 20121221
Silarx Pharmaceutical, Inc
Review RxNorm Normal Forms