DIPHENHYDRAMINE HYDROCHLORIDE
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diphenhydramine hydrochloride tablet, coated
New World Imports, Inc
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.
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Temporarily relieves these symptoms of the common cold: runny nose and sneezing.
Temporarily relieves symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itchy nose or throat, itchy, watery eyes.
Do not use with any other product containing diphenhydramine, even one used on skin.
Ask a doctor before use if you have:
A breathing problem such as emphysema or chronic bronchitis
Glaucoma
Difficulty in urination due to an enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives
When using this product:
Excitability may occur especially in children
Drowsiness may occur
Avoid alcoholic drinks
Alcohol, sedatives, and tranquilizers may increase drowsiness
Use caution when operating machinery or driving a motor vehicle
If pregnant or breast-feeding,ask a health professional before use.
Take every 4 to 6 hours, not more than 6 doses in 24 hours.
Adults and children 12 years of age and over: Take 1 or 2 tablets
Children 6 to under 12 years of age: Take 1 tablet
Children under 6 years of age: Consult a doctor
Children under 4 years of age:do not use
Carnauba wax, colloidal silicon dioxide croscarmellose sodium, D and C Red No 27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcyrstalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80 and titanium dioxide. May also contain: polyvinyl alcohol and talc.
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride tablet, coated |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part341 | 11/11/2010 |
Labeler - New World Imports, Inc (075372276) |
Revised: 02/2012 New World Imports, Inc