Safetussin Pm Nighttime Liquid
FDA Label NDC 55505-221

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Safetussin Pm Nighttime (NDC 55505-221). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredients (in each 5mL)

Purpose

Dextromethorphan HBr, USP 7.5 mg

Cough Suppressant

Doxylamine Succinate 3.125 mg

Antihistamine

Uses

  • ▪temporarily relieves cough
  • ▪runny nose and sneezing

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
    • ▪.to make a child sleep.

Ask A Doctor Before Use If You Have

  • ▪asthma
  • ▪emphysema
  • ▪glaucoma
  • ▪excessive phlegm (mucus)
  • ▪breathing problem
  • ▪chronic bronchitis
  • ▪persistent or chronic cough
  • ▪cough associated with smoking
  • ▪trouble urinating due to enlarged prostate gland
  • ▪a sodium-restricted diet

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When Using This Product

  • ▪do not use more than directed
  • ▪excitability may occur, especially in children
  • ▪marked drowsiness may occur
  • ▪avoid alcoholic drinks
  • ▪be careful when driving a motor vehicle or operating machinery
  • ▪alcohol, sedatives and tranquilizers may increase drowsiness

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Directions

  • ▪do not take more than 4 doses in any 24-hour period

    • age

    dose

    adults and children 12 years and over

    20 mL every 6 hours

    children under 12 years

    ask a doctor

    children under 4 years

    do not use

Other Information:

  • ▪Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F) Save this package for complete information

Inactive Ingredient

Inactive ingredients:

citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose

Principal Display Panel

SAFE FOR ADULTS WITH

HIGH BLOOD PRESSURE & DIABETES

Safetussin® PM 
NightTime
Cough Relief
Dextromethorphan HBr 7.5 mg / Cough Suppressant

Doxylamine Succinate 3.125 mg / Antihistamine

Safe for adults with
High Blood Pressure
Diabetes

√ Controls Cough
√ Relieves Sneezing
√ Relieves runny nose

SUGAR & ALCOHOL FREE

4.0 FL OZ (118mL)


SEGURO PARA ADULTOS CON PRESION ALTA Y DIABETES

Safetussin® PM
Alivia la Tos
Durante la Noche

Dextromethorphan HBr 7.5 mg / Antiusivo

Doxylamine Succinate 3.125 mg / Antihistaminíco

Seguro para adultos con
Presión Alta
Diabetes

√ Calma la tos,
√ Alivia estornudos
√ Alivia goteo de la nariz
 
SIN AZÚCAR Y SIN ALCOHOL

4 FL. OZ (118 mL)

Safetussin® PM
NIGHT TIME
COUGH RELIEF
Cough Suppressant / Antihistamine

Up To
8 Hours of cough relief 
to help you rest

Safetussin® PM contains:

√ No decongestants

√ No acetaminophen

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

© 2023 Kramer Laboratories, Inc.
Bridgewater, NJ 08807 ● kramerlabs.com
K0723

Safetussin Pm Nighttime Cough Relief 4.0 Fl Oz (118 mL) (Carton)

Safetussin Pm Nighttime Cough Relief 4.0 Fl Oz (118 mL) (Carton)

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