ONLY FOR ALLERGY- diphenhydramine hcl tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

O4 Global Trading Usa, Llc

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:    • runny nose    • sneezing    • itchy, watery eyes    • itching of the nose or throat • temporarily relieves these symptoms due to the common cold:    • runny nose    • sneezing

Authorization status:

OTC monograph final

Summary of Product characteristics

ONLY FOR ALLERGY- DIPHENHYDRAMINE HCL TABLET
O4 GLOBAL TRADING USA, LLC
_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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_ONLY FOR_ ALLERGY
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH CAPLET)_
Diphenhydramine HCl 25mg
_PURPOSE_
Antihistamine
_USES:_
• temporarily relieves these symptoms due to hay fever or other
upper respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• temporarily relieves these symptoms due to the common cold:
• runny nose
• sneezing
_WARNINGS:_
DO NOT USE
• to make a child sleepy
• 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
• 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.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
_™_
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
_DIRECTIONS:_
• take every 4 to 6 hours, or as directed by doctor
• do not take more than 6 doses in 24 hours
adults and children 12 years and
over
• take 1 to 2
caplets
children 6 to under 12 years
• take 1 caplet
children under 6 years
• do not use
_OTHER INFORMATION:_
• store between 20-25°C (68-77°F) excursions permitted between
15-30°C (59-86°F).
• avoid excessive heat and light.
• store in dry place.
_INACTIVE INGREDIENTS:_
croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminiu