Safetussin High Blood Pressure Nighttime Cold & Flu

SPL v4

SPL

SPL Set ID 279e309c-040d-4001-808d-b7d986a9a1d8

Route

ORAL

Published

Effective Date 2023-05-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Glycerin Menthol, Unspecified Form Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-04-17

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves common cold/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 30 mL dose cup)	Purpose
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant

Directions

▪
do not take more than directed
▪
do not take more than 6 doses in any 24-hours period
▪
measure only with dosing cup provided
▪
dose as follows or as directed by a doctor

adults & children 12 years & older	30 mL per dose every 4 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 6 doses in 24 hours, which is the maximum daily amount for this product
▪
taken with other drugs containing acetaminophen
▪
3 or more alcoholic drinks every day while using this product

Other Information

•
each 30 mL contains: sodium19 mg
•
store at room temperature. Do not refrigerate.

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

Anhydrous citric acid, edetate disodium, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.

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 55505-217-36

Safetussin®

MAX STRENGTH

MULTI-SYMPTOM

Cough, Cold & Flu

Acetaminophen / Pain Reliever 650 mg

Dextromethorphan HBr / Cough Suppressant 20 mg

Guaifenesin / Expectorant 400 mg

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

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.

8 FL OZ (237 mL)

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

Ask A Doctor Or Pharmacist Before Use If You Are

▪
taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves common cold/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 30 mL dose cup)	Purpose
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant

Directions

▪
do not take more than directed
▪
do not take more than 6 doses in any 24-hours period
▪
measure only with dosing cup provided
▪
dose as follows or as directed by a doctor

adults & children 12 years & older	30 mL per dose every 4 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 6 doses in 24 hours, which is the maximum daily amount for this product
▪
taken with other drugs containing acetaminophen
▪
3 or more alcoholic drinks every day while using this product

Other Information (Other information)

•
each 30 mL contains: sodium19 mg
•
store at room temperature. Do not refrigerate.

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)

Anhydrous citric acid, edetate disodium, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.

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 55505-217-36

Safetussin®

MAX STRENGTH

MULTI-SYMPTOM

Cough, Cold & Flu

Acetaminophen / Pain Reliever 650 mg

Dextromethorphan HBr / Cough Suppressant 20 mg

Guaifenesin / Expectorant 400 mg

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

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.

8 FL OZ (237 mL)

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

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

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves common cold/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 30 mL dose cup) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant", "Directions": "▪ do not take more than directed ▪ do not take more than 6 doses in any 24-hours period ▪ measure only with dosing cup provided ▪ dose as follows or as directed by a doctor adults & children 12 years & older 30 mL per dose every 4 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 6 doses in 24 hours, which is the maximum daily amount for this product ▪ taken with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks every day while using this product", "Other information": "• each 30 mL contains: sodium19 mg • store at room temperature. Do not refrigerate.", "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": "Anhydrous citric acid, edetate disodium, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.", "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 55505-217-36 Safetussin® MAX STRENGTH MULTI-SYMPTOM Cough, Cold & Flu Acetaminophen / Pain Reliever 650 mg Dextromethorphan HBr / Cough Suppressant 20 mg Guaifenesin / Expectorant 400 mg 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 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. 8 FL OZ (237 mL) Questions? Comments? Call 1-800-824-4894 ©2023 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: 2026-02-15T12:07:56.443692 · Updated: 2026-03-14T23:11:56.566307