SAFETUSSIN NON DROWSY COUGH PLUS CHEST CONGESTION- dextromethorphan hydrobromide, and guaifenesin liquid

SAFETUSSIN Non Drowsy by

Drug Labeling and Warnings

SAFETUSSIN Non Drowsy by is a Otc medication manufactured, distributed, or labeled by KRAMER LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 30 mL dose cup)	Purpose
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

Uses

• ▪ temporarily relieves cough due to minor throat and bronchial irritation
• ▪ loosen phlegm (mucus)
• ▪ helps rid bronchial passages of phlegm(mucus)

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

• ▪ cough that occurs with too much phlegm (mucus)
• ▪ 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 persistent headache.
  
  These could be signs of a serious condition.

If pregnant or breast-feeding, ask a 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 take more than 6 doses in any 24-hours period
• ▪ This adult product is not intended for use in children under 12 years of age

• age:

  dose

• Adults and children 12 years and over:

  10 mL every hours

• Children under 12 years:

  do not use

Other information

• Protect from excessive heat and freezing. Store at 15° - 30°C (59° - 86°F)

  Save this package for complete information

Inactive ingredients

citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose,

Questions? Comments?

Call 1-800-824-4894

SPL UNCLASSIFIED SECTION

Distributed by

©2023 Kramer Laboratories, Inc Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES

Safetussin® DM

NON-DROWSY

Cough+Chest

Congestion

Dextromethorphan HBr 10 mg / Cough Suppressant

Guaifenesin 100 mg/ Expectorant

Safe for adults with

High Blood Pressure

Diabetes

• ✓ Control cough
• ✓ Loosens mucus
• ✓ Relives chest congestion

SUGAR & ALCOHOL FREE

8.0 FL OZ (237mL)

Safetussin® DM contains:

• ✓ No decongestants
• ✓ No acetaminophen
• ✓ No Sugar
• ✓ No Alcohol
• ✓ No sorbitol
• ✓ No fructose
• ✓ No gluten
• ✓ No dyes

Pharmacist Recommended Brand

Always read and follow label directions. Do not use longer than 7 consecutive days unless directed by a doctor. Ask a doctor if you have individual health questions.

Questions? Comments? Call 1-800-824-4894

©2023 Kramer Laboratories, Inc. Bridgewater, NJ 08807

K0423

SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES

Safetussin® DM

NON-DROWSY

Cough+Chest

Congestion

Dextromethorphan HBr / Cough Suppressant Guaifenesin / Expectorant

Safe for adults with

High Blood Pressure

Diabetes

• ✓ Control cough
• ✓ Loosens mucus
• ✓ Relives chest congestion

SUGAR & ALCOHOL FREE

4.0 FL OZ (118mL)

Safetussin® DM contains:

• ✓ No decongestants
• ✓ No acetaminophen
• ✓ No Sugar
• ✓ No Alcohol
• ✓ No sorbitol
• ✓ No fructose
• ✓ No gluten
• ✓ No dyes

Pharmacist Recommended

Always read and follow label directions. Ask a doctor if you have individual health questions.

Questions? Comments?
Call 1-800-824-4894

©2020 Kramer Laboratories, Inc.
Bridgewater, NJ 08807

K0820

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY
SEAL ON BOTTLE IS BROKEN OR MISSING.

K0820

INGREDIENTS AND APPEARANCE

SAFETUSSIN NON DROWSY  COUGH PLUS CHEST CONGESTION
dextromethorphan hydrobromide, and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-220
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
MINT (UNII: FV98Z8GITP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-220-36	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2023
2	NDC: 55505-220-33	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2023

Labeler - KRAMER LABORATORIES (122720675)