Label: DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet
- NDC Code(s): 76457-002-00
- Packager: Simpex Pharma Pvt. Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: 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.
Updated November 15, 2012
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- Active ingredient (in each tablet)
Diphenhydramine hydrochloride 25 mgClose
Temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract
- runny nose
- Ichy watery eyes
- Iching of the nose or throat.
Keep outer carton for complete warning and product information.Close
- 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
- 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.
- Pregnancy or breast feeding
If Pregnant or breast-feeding, ask a health professional before use.Close
- 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.Close
- When using this product
- marked drowsiness may occur
- avoid alcoholic drinks
- 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.Close
- Questions or comments?
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- Package Label
Antihistamine 100 tablets
- Temporarily relieves symptoms due to common cold hay fever or other allergies affecting the upper respiratory tract.
- Runny nose
- Ichy watery eyes
- Iching of the nose or throat
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
Lot. No. :
- INGREDIENTS AND APPEARANCE
diphenhydramine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76457-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL (UNII: 532B59J990) WATER (UNII: 059QF0KO0R) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (white) Score no score Shape ROUND (round) Size 8mm Flavor Imprint Code ; Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76457-002-00 1 in 1 CARTON 1 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/15/2012 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)