diphenhydramine hydrochloride tablet
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
In case of overdose, get medical help or contact a Poison Control Center right away.This package is intended for institutional use only. Keep this and all drugs out of the reach of children. This unit dose package is not child resistant.
￭temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
￭runny nose ￭itchy, watery eyes
￭sneezing ￭itching of the nose or throat
￭temporarily relieves these symptoms due to the common cold:
￭runny nose ￭sneezing
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Do not use ￭to make a child sleepy
￭with any other product containing diphendydramine, even one used on skin
Ask a doctor before use if you have
￭a breathing problem such as emphysema or chronic bronchitis
￭trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
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
￭take every 4 to 6 hours
￭do not take more than 6 doses in 24 hours
adults and children
12 years of age and over 1 to 2 tablets
children 6 to under
12 years of age 1 tablet
children under 6 years of age do not use this product in chil-
dren under 6 years of age
Corn Starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
￭Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature.]
￭Protect from moisture.
￭use by expiration date on blister package
￭Serious side effects associated with use of this products may be reported to this number.
Diphenhydramine Hydrochloride Tablets are available as follows:
25 mg - Pink film coated capsule shaped tablet imprinted with 44-329 on one side.
NDC 51079-967-20 - Unit dose blister packages of 100 (10 cards or 10 tablets each).
NDC51079-967-19 - Robot Ready blister packages of 25 (25 cards of 1 tablet each).
LNK International, Inc.
Hauppauge, NY 11788
UDL Laboratories, Inc.
Rockford, IL 61103
diphenhydramine hcl tablet
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|Unapproved drug other||06/03/2011|
|Labeler - Cardinal Health (188557102)|
Revised: 06/2011 Cardinal Health