CHLORPHENIRAMINE- chlorpheniramine maleate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)

Available from:

L&R Distributors, Inc.

INN (International Name):

CHLORPHENIRAMINE MALEATE

Composition:

CHLORPHENIRAMINE MALEATE 4 mg

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 - itchy, watery eyes - sneezing - itching of the nose or throat

Authorization status:

OTC monograph final

Summary of Product characteristics

CHLORPHENIRAMINE- CHLORPHENIRAMINE MALEATE TABLET
L&R DISTRIBUTORS, 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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SELECT BRAND 44-194-DELISTED
_ACTIVE INGREDIENT (IN EACH TABLET)_
Chlorpheniramine maleate 4 mg
_PURPOSE_
Antihistamine
_USES_
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
_WARNINGS_
DO NOT USE
to make a child sleepy.
ASK A DOCTOR BEFORE USE IF YOU HAVE
glaucoma
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
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution 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 (1-800-222-1222) right away.
_DIRECTIONS_
adults and children 12 years of age
and over
1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24
hours.
children 6 to under 12 years of age
1/2 tablet (break tablet in half) every 4 to 6 hours. Do not exceed 3
whole tablets in 24 hours.
children under 6 years of age
do not use this product in children under 6 years of age
_OTHER INFORMATION_
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS
TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC
(59º-86ºF)
see end flap for expiration date and lot number
_INACTIVE INGREDIENTS_
corn starch, D&C yellow #10 aluminum lake, lactose anhydrous,
magnesium stearate, microcrystalline
ce