NDC | 69168-302-93 |
Set ID | 439b0113-2b2b-4369-b019-1437e5720f7c |
Category | HUMAN OTC DRUG LABEL |
Packager | Allegiant Health |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredient
- Purpose
- Uses
-
Warnings
Do Not Use
if you are now taking a prescription monoamine oxadise 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- diabetes
- heart disease
- high blood pressure
- thyroid disease
When using this product
- do not use more than directed
- may cause excitability, especially in children
- may cause drowsiness; alcohol, sedatives or tranquilizers may increase drowsiness
- avoid alcoholic beverages and use caution when driving a motor vehicle or operating machinery
- Keep Out of Reach of Children
- Directions
- Other Information
- Inactive Ingredients
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
COLD AND ALLERGY
phenylephrine hcl and chlorpheniramine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-302 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) STARCH, 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 7mm Flavor Imprint Code T127 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-302-93 1 in 1 CARTON 12/23/2014 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 12/23/2014 Labeler - Allegiant Health (079501930)