Cough Syrup DM

Manufacturer
Cintas Corporation | Ultratab Laboratories, Inc. | Ultra Seal Corporation
Effective date
2021-01-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:57:42

Label at a glance#

ProductCough Syrup DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 5 ml)  Guaifenesin 100 mg, Dextromethorphan HBr 10 mg

OTC - PURPOSE SECTION

Purpose-Cough Suppressant, Expectorant

INDICATIONS & USAGE SECTION

Uses ■ temporarily relieves cough due to minor throat and
bronchial irritation that occur with a cold or inhaled irritants
■ helps loosen phlegm (mucus) and thin bronchial secretions to
make coughs more productive

DOSAGE & ADMINISTRATION SECTION

Directions

  • shake well before using
  • adults and children over 12 years: take

2 teaspoons (one packet) every 4 hours

  •  do not exceed 12 teaspoons (6 packets) in 24 hours
  •  children under 12 years: do not use

WARNINGS SECTION


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.
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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. In case of overdose,  
get medical help or contact a Poison Control Center right away.  
Prompt medical attention is critical for adults as well as for  
children even if you do not notice any signs or symptoms.

INACTIVE INGREDIENT SECTION

Inactive ingredients
citric acid, FDC red 40, flavor, glycerin, methyl
paraben, propylene glycol, propyl paraben, purified
water, sodium citrate, sucralose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM1Cough Syrup BoxCough Syrup Box1

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-05342961-053-01, 42961-053-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
03b4affa-fb64-4b68-a03d-09b5d2961deab61cf9cb-23ca-4cc8-9f31-6d76a5d76d9e2022-12-30WarningsExact identifier
spl set id: b61cf9cb-23ca-4cc8-9f31-6d76a5d76d9e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.