SDA LABORATORIES TUSSIN DM- dextromethorphan hbr, guaifenesin liquid

SDA Laboratories Tussin DM by

Drug Labeling and Warnings

SDA Laboratories Tussin DM by is a Otc medication manufactured, distributed, or labeled by SDA Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

per 5 mL teaspoonful

Dextromethorphan HBr - 10 mg

Guaifenesin - 100 mg

PURPOSE

Purpose

Cough Suppressant

Expectorant

INDICATIONS & USAGE

Uses

• temporarilyrelievescoughduetominorthroatand bronchial irritation
• helps loosen phlegm (mucus)
• helps thin bronchial secretions to make coughs more productive

WARNINGS

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.

Do not useif you have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

• a cough with too much phlegm (mucus)
• a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

cough lasts more than 7 days, comes back or is accompanied by fever, rash, or headache that lasts. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• take every 4 hours as needed, or as directed by a doctor
• do not take more than 6 doses in 24 hours
• do not exceed recommended dose

• Adults and children 12 years and over: 2 teaspoonfuls (10 mL)
• Children under 12 years: do not use

INACTIVE INGREDIENT

Inactive ingredients:artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose

QUESTIONS

Questions or Comments? 1-203-861-0005

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SDA LABORATORIES TUSSIN DM 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66424-565
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66424-565-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/01/2024

Labeler - SDA Laboratories, Inc. (948067889)