Label: CHLORPHENIRAMINE MALEATE tablet
Contains inactivated NDC Code(s)
NDC Code(s): 61919-402-30, 61919-402-71
- Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 0904-0012
- 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 December 8, 2015
If you are a consumer or patient please visit this version.
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INDICATIONS & USAGE SECTION
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Do not use
to make a child sleepy.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
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
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.
- Do not use
DOSAGE & ADMINISTRATION SECTION
adults and children
12 years of age
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
- INFORMATION FOR PATIENTS SECTION
- INACTIVE INGREDIENT SECTION
- OTC - QUESTIONS SECTION
Do not use
to make a child sleepy.
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
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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
chlorpheniramine maleate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-402(NDC:0904-0012) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color yellow Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code 44;194 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-402-71 1 in 1 CARTON; Type 0: Not a Combination Product 01/01/2014 2 NDC:61919-402-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2014 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 relabel(61919-402) , repack(61919-402)