Label: LITTLE REMEDIES LITTLE COLDS MUCUS RELIEF EXPECTORANT MELT AWAYS- guaifenesin granule
-
Contains inactivated NDC Code(s)
NDC Code(s): 63029-101-12 - Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 18, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
-
Warnings
Ask a doctor before use if you have:
- Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- Cough that occurs with too much phlegm (mucus)
- Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
-
Directions
- Empty entire contents of packet onto tongue, allow to dissolve, then swallow
- For best taste, do not chew granules
- Do not take more than 6 doses in any 24-hour period
Age Dose Under 4 years Do not use 4 – under 6 years 1 packet every 4 hours 6 to under 12 years 1 – 2 packets every 4 hours 12 years and over 2 – 4 packets every 4 hours - Empty entire contents of packet onto tongue, allow to dissolve, then swallow
- Other Information
- Inactive Ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LITTLE REMEDIES LITTLE COLDS MUCUS RELIEF EXPECTORANT MELT AWAYS
guaifenesin granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg Product Characteristics Color WHITE Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-101-12 12 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 12/31/2009 Labeler - Medtech Products Inc. (122715688)
