FDA.reportPublic FDA data

CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD

Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date
2020-11-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 23:06:12

Label at a glance#

ProductCHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Storage and handling

Other information • each 10 ml contains: sodium 6 mg • store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredients (in each 10 ml)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate, USP 2.0 mg

Dextromethorphan HBr, USP 15 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

  • to sedate a child or to make a child sleepy
  • 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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 SECTION

If pregnant or breast-feeding, 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than 4 doses in any 24-hour period
  • measure only with dosage cup provided
  • keep dosage cup with product
  • ml = milliliter
agedose

12 years and over

20 ml every 6 hours

6 to under 12 years

10 ml every 6 hours

under 6 years

do not use

STORAGE AND HANDLING SECTION

Other information

  • each 10 ml contains: sodium 6 mg
  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

OTC - QUESTIONS SECTION

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

SPL UNCLASSIFIED SECTION

Distributed by:
Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0031-2238-13

Children's
Dimetapp®

CHLORPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)

up to
8 hours
of cough
control

Long Acting
Cough
Plus Cold

Relieves Nasal Symptoms

  • Runny Nose
  • Sneezing

Plus Other Symptoms

  • Itchy, Watery Eyes
  • Cough

For Ages
6 Yrs.
& Over

4 FL OZ (118 ml) alcohol-free • grape flavor

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-2238-13ML - Milliliter0031-22385e4cf6f6-7a84-441b-9ed0-1a8b9237931b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9Z1
dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYH1
chlorpheniramineACTIVE MOIETY3U6IO1965U1
dextromethorphanACTIVE MOIETY7355X3ROTS1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-22380031-2238-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
30881731-2300-41c7-a079-9ef8773e542f059a3e6e-ea98-b0c5-ba27-b7cbbdedc9172021-06-09WarningsExact identifier
spl set id: 059a3e6e-ea98-b0c5-ba27-b7cbbdedc917

Reported adverse events (FAERS/openFDA)#

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