Safetussin Non-drowsy Cough + Chest Congestion

Safetussin Non-drowsy Cough + Chest Congestion
SPL v3
SPL
SPL Set ID eeca6370-29ea-4540-8139-e8461d58a286
Route
ORAL
Published
Effective Date 2024-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
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 cough due to minor throat and bronchial irritation
  • loosen phlegm (mucus)
  • helps rid bronchial passages of phlegm(mucus)
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

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

Section 55105-1
Active ingredients (in one caplet) Purpose

Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg

Expectorant

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.

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.
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

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.
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
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

Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation
  • loosen phlegm (mucus)
  • helps rid bronchial passages of phlegm(mucus)
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in one caplet) Purpose

Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg

Expectorant

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.

Do Not Use (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.
Other Information (Other information)
  • Store at 15° - 30°C (59° - 86°F)
  • Keep this carton for future reference on full labeling
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

Stop Use and Ask A Doctor If (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.
Ask A Doctor Before Use If You Have (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
Principal Display Panel 236 Ml Bottle Label (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

Advanced Ingredient Data


Raw Label Data

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