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

SAFETUSSIN Non Drowsy by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in one caplet)	Purpose
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 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

• adults and children 12 years and over: take 1-2 caplets every 4 hours as needed.
• Children under 12 years:do not use

  Do not take more than 12 caplets in any 24-hour period.

Other information

• Store at 15° - 30°C (59° - 86°F)
• Keep this carton for future reference on full labeling

Inactive ingredients

Crospovidone, flavor, Hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, stearic acid, sucralose,

Questions or Comments?

1-866-467-2748

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Distributed by

©2024 Kramer Laboratories, Inc Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES

NDC: 55505-231-24

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 & DECONGESTANT FREE

24 Caplets

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-231
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Caplets)	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-231-24	24 in 1 CARTON; Type 0: Not a Combination Product	05/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/17/2024

Labeler - KRAMER LABORATORIES (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
RARITAN PHARMACEUTICALS INCORPORATED		127602287	manufacture(55505-231)