SAFETUSSIN MAX STRENGTH MS COUGH, COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and guaifenesin tablet

SAFETUSSIN MAX STRENGTH MS by

Drug Labeling and Warnings

SAFETUSSIN MAX STRENGTH MS 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 each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant

Uses

• temporarily relieves common cold and flu symptoms:
• cough
• sore throat
• headache
• minor aches and pains
• fever
• helps loosen phlegm (mucus) and thin bronchial secretions to get rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4000mg of acetaminophen in 24 hours, which is the maximum daily amount for this product in 24 hours
• taken with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:

• Skin reddening
• Blisters
• Rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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.
• If you have ever had an allergic reaction to this product r any of its ingredients
• In children under 12 years of age

Ask a doctor before use if you have

• liver disease
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

When using this product

• Do not use more than as directed

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts.
  
  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.

Directions

• do not use more than directed.

• adults & children 12 years & over:

  Take 2 caplets every 4 hours (do not take more than 12 caplets in 24 hours)

• children under 12 years of age:

  do not use

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

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES

NDC: 55505-230-24

Safetussin®

MAX STRENGTH

MULTI-SYMPTOM

Cough, Cold & Flu

Acetaminophen / Pain Reliever

Dextromethorphan HBr / Cough Suppressant

Guaifenesin / Expectorant

Safe for adults with

High Blood Pressure

Diabetes

Relieves

• Headache
• Fever
• Sore Throat
• Body Aches & Pains
• Chest Congestion
• Cough

Safetussin® contains:

No decongestants

No Sugar

No Alcohol

No sorbitol

No fructose

No gluten

No dyes

SUGAR & DECONGESTANT FREE

24 Caplets

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.

©2024 Kramer Laboratories, Inc. Bridgewater, NJ 08807

INGREDIENTS AND APPEARANCE

SAFETUSSIN MAX STRENGTH MS  COUGH, COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-230
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
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 (Caplet)	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-230-24	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(55505-230)