NDC | 10956-761-01, 10956-761-50 |
Set ID | 98e6d6ba-4164-4a14-b186-a5016c7e4c33 |
Category | HUMAN OTC DRUG LABEL |
Packager | Reese Pharmaceutical Co |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- ASK DOCTOR
- STOP USE
-
DO NOT USE
Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)
Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease
or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains
an MAIO, ask your doctor or pharmacist before using this product.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- INACTIVE INGREDIENT
-
DOSAGE & ADMINISTRATION
Directions
• Adults and children 12 years of age and over:
take 1 tablet every 4 hours as needed
• Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed
• Children under 6 years of age: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other information store at 15'- 30' C (59'- 86'F) Rev 10/U9 RCCF - INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FREDS CHEST CONGESTION RELIEF DM
dextromethorphan hydrobromide / guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10956-761 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg Product Characteristics Color white Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code PH073 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10956-761-01 1 in 1 CARTON 1 NDC:10956-761-50 50 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/30/2009 Labeler - Reese Pharmaceutical Co (004172052) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Reese Pharmaceutical Co 004172052 relabel, repack Establishment Name Address ID/FEI Business Operations Pharbest 557054835 manufacture