Label: CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE- chlorpheniramine maleate and phenylephrine hydrochloride tablet, coated
- NDC Code(s): 57344-158-02
- Packager: AAA Pharmaceutical, Inc.
- 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 September 11, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- high blood pressure
- heart disease
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousnous, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or occur with fever
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
chlorpheniramine maleate and phenylephrine hydrochloride tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-158 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code T127 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57344-158-02 1 in 1 CARTON 06/01/2019 1 24 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2019 Labeler - AAA Pharmaceutical, Inc. (181192162)