NDC | 69842-189-62, 69842-189-67 |
Set ID | 62ba0f8f-15cc-48a6-ad58-7df6795a6af2 |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS Pharmacy |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredient (in each softgel)
- Purpose
- Uses
- Warnings
-
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
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
adults and children 12
years and over
- •
- take 2 softgels every 4 to 6 hours
- •
- do not take more than 8 softgels in 24 hours
children ages 6 to under 12 years
- •
- take 1 softgel every 4 to 6 hours
- •
- do not take more than 4 softgels in 24 hours
children under 6 years
do not use this product in children under 6 years of age
- Other information
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
NASAL DECONGESTANT
pseudoephedrine hydrochloride capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-189 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GUAR GUM (UNII: E89I1637KE) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED Score no score Shape OVAL Size 17mm Flavor Imprint Code PT3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-189-62 24 in 1 CARTON 02/09/2017 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:69842-189-67 48 in 1 CARTON 07/20/2017 2 1 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 02/09/2017 Labeler - CVS Pharmacy (062312574)