Safetussin Ms Cough, Cold & Flu

SPL v2

SPL

SPL Set ID 920bde5f-4079-45de-aa59-24b00e50cb56

Route

ORAL

Published

Effective Date 2024-06-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg)

Inactive Ingredients

Crospovidone (120 .mu.m) Hypromellose 2208 (100 Mpa.s) Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Silicon Dioxide Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance

Shape: oval Color: white Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-17

Description

Drug Facts

Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1

Active ingredients (in each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant

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

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

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

Other Information

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

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.

Inactive Ingredients

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

Questions Or Comments

1-866-467-2748

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.

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

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.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients (in each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant

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

Do Not Use (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

Liver Warning (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

Other Information (Other information)

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

Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments (Questions or comments)

1-866-467-2748

When Using This Product (When using this product)

Do not use more than as directed

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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

Principal Display Panel 236 Ml Bottle Label (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.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant", "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", "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", "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", "Other information": "store at 15°-30°C (59° - 86°F). Keep this carton for future reference on full labeling.", "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.", "Inactive ingredients": "Crospovidone, flavor, Hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, stearic acid, sucralose.", "Questions or comments": "1-866-467-2748", "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.", "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", "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", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:57.270330 · Updated: 2026-03-14T23:12:00.901105