DR. SANA COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin liquid

DR. SANA COUGH AND CHEST CONGESTION DM by

Drug Labeling and Warnings

DR. SANA COUGH AND CHEST CONGESTION DM by is a Otc medication manufactured, distributed, or labeled by GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients: (in each 30ml)

Dextromethorphan HBr 20 mg
Guaifenesin 200 mg

Purpose

Cough Suppressant
Expectorant 

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. 

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

do not exceed more than 6 doses in any 24-hour period
shake well before use
mL=milliliter

• age: dose
• adults and children 12 years & more: 2 tablespoons (30 mL) every 4 hours
• children under 12 years of age: consult your doctor

Other information

Store this product between 15°C to 30°C (59° to 86°F)
Tamper evident feature: Do not use this product if imprinted cello-band over cap is torn, broken or missing.

Inactive ingredients:

Aloe Vera, Citric Acid, Caramel Color, Corn Syrup, Eucalyptus Oil, Ginger Root PE, Honey, Natural and Artificial Honey Flavor, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum.

Questions?

call Weekdays from 9:30 AM to 5 PM EST at Tel. 305-633-7900

SPL UNCLASSIFIED SECTION

Relieves:
COUGH
CHEST CONGESTION

with Natural Ingredients
ALOE
HONEY
GINGER
EUCALYPTUS

NON DROWSY NO GLUTEN

Distributed by:
Healthtex Distributors, LLC
Miami, Florida 33142
info@healthtexusa.com

Made in USA

TAMPER EVIDENT FEATURE: DO NOT USE THIS PRODUCT IF IMPRINTED CELLO-BAND OVER CAP IS TORN BROKEN OR MISSING

Packaging

INGREDIENTS AND APPEARANCE

DR. SANA COUGH AND CHEST CONGESTION DM 
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-514
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)
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GINGER (UNII: C5529G5JPQ)
HONEY (UNII: Y9H1V576FH)
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: 53113-514-06	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(53113-514)