RxNorm Names
DIPHENHYDRAMINE HYDROCHLORIDE tablet
[Simpex Pharma Pvt. Ltd]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82771f6a-8b3d-4ffa-8b35-09c2faf3582c| 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 symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract
- runny nose
- sneezing
- Ichy watery eyes
- Iching of the nose or throat.
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin.
Consult a doctor
if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- sedative, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability my 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
- take every 4 to 6 hours
- do not take more than 6 does in 24 hours
- Adult and children 12 years of age and over - 1 to 2 tablet
- Children 6 to 12 years of age - 1 tablet
- Children 6 years of age - do not use this product in children under 6 years
- Children under 4 years of age - do not use
Other Information
- each tablet contains: Calcium 25 mg/tablet
- store at room temperature 15 to 30 degrees Celsius (59 degrees to 86 degrees Fahrenheit)
- protect from light and moisture
- do not use if imprented safety seal under cap is broken or missing.
Inactive ingredient
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, opadry AMB white*, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide. *contains one or more of these ingredients.
Package Label
Antihistamine 100 tablets
Diphenhydramine hydrochloride
Anti-Allergy Tablets
- Temporarily relieves symptoms due to common cold hay fever or other allergies affecting the upper respiratory tract.
- Runny nose
- Sneezing
- Ichy watery eyes
- Iching of the nose or throat
Manufactured by:
SIMPEX PHARMA PVT. LTD.
C-7 to C-13 and C-59 to C-64, Siggadi Growth Center
(SIDCUL), Siggadi, Kotdwar-246149,
District Pauri Garhwal, Uttrakhand, India
Distributed by:
Lot. No. :
Mfg.Date:
Exp.Date:


| DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride tablet |
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| Labeler - Simpex Pharma Pvt. Ltd (916758275) |
| Registrant - Simpex Pharma Pvt. Ltd (916758275) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Simpex Pharma Pvt. Ltd | 916758275 | manufacture(76457-002) | |
Revised: 11/2012
Document Id: 02ac9591-9bec-49ef-8751-feb461860024
Set id: 82771f6a-8b3d-4ffa-8b35-09c2faf3582c
Version: 1
Effective Time: 20121115
Simpex Pharma Pvt. Ltd
Review RxNorm Normal Forms