Label: ALLERGY- chlorpheniramine maleate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 33261-222-30 - Packager: Aidarex Pharmaceuticals LLC
- 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.
Drug Label Information
Updated December 16, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
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
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Directions
adults and children 12 years of age and older 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 tablets in 24 hours. children under 6 years of age
do not use this product in children under 6 years of age
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 33261-0222-30
Allergy
Tablets
AntihistamineRELIEVES: Sneezing,
Itchy, Watery Eyes,
Itchy Throat, Runny Nose*Compare to the active ingredient in Chlor-Trimeton® Allergy Tablets
Chlorpheniramine maleate 4 mg EACH
4 hour
24 TABLETS*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Chlor-Trimeton® Allergy Tablets.
50844 REV0512K19408Distributed by Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USARepackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880REV. 05/12
M-17TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
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INGREDIENTS AND APPEARANCE
ALLERGY
chlorpheniramine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33261-222(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 no score Shape ROUND Size 8mm Flavor Imprint Code 44;194 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33261-222-30 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/19/1992 Labeler - Aidarex Pharmaceuticals LLC (801503249)