Label: GUAIFENESIN tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 54868-5847-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5154
- 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 March 1, 2012
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 immediate-release tablet)
- Purpose
- Use(s)
-
Warnings
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions?
-
Principal Display Panel
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
NDC 54868-5847-0
GUAIFENESIN TABLETS
Guaifenesin 200 mg
Expectorant- Relieves Chest Congestion
- Thins and Loosens Mucus
50844 REV0510A58812
Distributed by MAJOR PHARMACEUTICALS
31788 Enterprise Drive,
Livonia, MI 48150 USA
Re-Order No. 238163 M-17 Rev. 11/10
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
-
INGREDIENTS AND APPEARANCE
GUAIFENESIN
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5847(NDC:0904-5154) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color PINK (dark) Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;588 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5847-0 1 in 1 CARTON 1 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 01/07/2008 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel