Label: DR. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE- dextromethorphan hydrobromide, guaifenesin syrup
- NDC Code(s): 53113-515-06
- Packager: GADAL Laboratories, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 23, 2025
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients: (in each 30 ml)
- Purpose
- Uses
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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 • A cough that is accompanied by excessive phlegm (mucus) • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Stop use and ask the doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
If pregnant or breast-feeding, ask health professional before use.
- Directions:
- Other information
- Inactive ingredients
- Questions?
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SPL UNCLASSIFIED SECTION
FORMULATED FOR DIABETICS
Helps Chest Congestion & Loosens Mucus
Aloe,
Ginger,
Eucalyptus.SYRUP WITH
NATURAL
INGREDIENTS• NO ALCOHOL • NO GLUTEN
Distributed by:
Healthtex Distributors, LLC
Miami, Florida 33142
info@healthtexusa.comMade in USA
TAMPER EVIDENT FEATURE: DO NOT USE THIS PRODUCT IF IMPRINTED CELLO-BAND OVER CAP IS TORN, BROKEN OR MISSING.
- Packaging
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INGREDIENTS AND APPEARANCE
DR. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE
dextromethorphan hydrobromide, guaifenesin syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-515 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 in 30 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CARAMEL (UNII: T9D99G2B1R) EUCALYPTUS OIL (UNII: 2R04ONI662) GINGER (UNII: C5529G5JPQ) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53113-515-06 1 in 1 BOX 04/14/2025 1 180 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/14/2025 Labeler - GADAL Laboratories, Inc (841305639) Establishment Name Address ID/FEI Business Operations GADAL Laboratories, Inc 841305639 manufacture(53113-515)

