FDA.reportPublic FDA data

Daytime Cold and Cough and NightTime Cold and Congestion

Manufacturer
TARGET Corporation
Effective date
2024-07-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:59:39

Label at a glance#

ProductDaytime Cold and Cough and NightTime Cold and Congestion Childrens
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Indications and uses

Nighttime temporarily relieves nasal congestion cough runny nose sneezing itchy, watery eyes due to hay fever itching of the nose or throat temporarily restores freer breathing through the nose Daytime temporarily relieves nasal congestion runny nose cough sneezing itching of the nose or throat itchy, watery eyes temporarily restores freer breathing through the nose

Dosage and administration

Nighttime do not take more than 6 doses in any 24 hours period measure only with dosing cup provided. keep dosing cup with product mL = milliliter Age Dose   adults and children 12 years and over  20 mL every 4 hours  children 6 to under 12 years  10 mL every 4 hours   children under 6 years  do not use Daytime do not take more than 6 doses in any 24 hours period measure only with dosing cup provided. keep dosing ...

Storage and handling

Nighttime each 10 mL contains : sodium 6 mg store at room temperature Daytime each 10 mL contains : sodium 6 mg store at room temperature

Label contents#

Full prescribing information#

Active ingredients for Nighttime (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg 

Active ingredients for Daytime (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Brompheniramine Maleate 2 mg

Dextromethorphan HBr 10mg 

Phenylephrine HCl 5 mg

Purpose for Nighttime

OTC - PURPOSE SECTION

Antihistamine / Cough suppressant

Nasal Decongestant

Purpose for Daytime

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Nighttime

  • temporarily relieves
  • nasal congestion
  • cough
  • runny nose
  • sneezing
  • itchy, watery eyes due to hay fever
  • itching of the nose or throat
  • temporarily restores freer breathing through the nose

Daytime

  • temporarily relieves
  • nasal congestion
  • runny nose
  • cough
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

Nighttime

  • 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
  • with any other product containing diphenhydramine, even one used on skin.

Daytime

  • to sedate a child or to make 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

Nighttime

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that last as occurs with smoking, asthma, chronic bronchitis or emphysema

Daytime

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Nighttime

  • taking any other oral nasal decongestant or stimulant
  • taking sedative or tranquilizers

Daytime

  • taking any other oral nasal decongestant or stimulant
  • taking sedative or tranquilizers

When using these products

OTC - WHEN USING SECTION

Nighttime

  • do not use more than directed
  • may cause marked drowsiness
  • 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

Daytime

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

Nighttime

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not get better within 7 days or accompanied by fever
  • 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

Daytime

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Nighttime

ask a health professional before use.

Daytime

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Nighttime

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Daytime

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

Nighttime

  • do not take more than 6 doses in any 24 hours period
  • measure only with dosing cup provided.
  • keep dosing cup with product
  • mL = milliliter

Age

Dose 

 adults and children 12 years and over

 20 mL every 4 hours

 children 6 to under 12 years

 10 mL every 4 hours

  children under 6 years

 do not use

Daytime

  • do not take more than 6 doses in any 24 hours period
  • measure only with dosing cup provided.
  • keep dosing cup with product
  • mL = milliliter

Age 

Dose 

 adults and children12 years and over

 20 mL every 4 hours

 children 6 to under 11 years

 10 mL every 4 hours

 Children under 6 years

 do not use

Other information

STORAGE AND HANDLING SECTION

Nighttime

  • each 10 mL contains: sodium 6 mg
  • store at room temperature

Daytime

  • each 10 mL contains: sodium 6 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Nighttime

citric acid, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose

Daytime

citric acid, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Nighttime

1-866-467-2748

Daytime

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredients in Children's Dimetapp® Nighttime Cold & Congestion**

NDC 82442-647-08

Children's Nighttime

Cold & Congestion

Diphenhydramine HCl (Antihistamine-Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves + comforts:

  • stuffy nose, runny nose
  • sneezing
  • itchy, watery eyes
  • cough

For Ages 6 Years and Over

No Added Alcohol

Grape Flavor

IMPORTANT: Keep this carton for future reference on full labeling

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING.

**This product is not manufactured or distributed by Foundation Consumer Brands, LLC, the distributor of Children's Dimetapp® Nighttime Cold & Congestion.

DAYTIME

Compare to active ingredients in Children's Dimetapp® Cold & Cough*

Children's

Cold & Cough

Brompheniramine Maleate (Antihistamine)

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCI (Nasal Decongestant)

Relieves + comfort

  • stuffy nose, runny nose
  • cough
  • itchy, watery eyes
  • sneezing

For Ages 6 Years and Over

No Added Alcohol

Grape Flavor

Naturally and artificially Flavored

2 – 4 FL OZ (118 mL) BOTTLES / TOTAL 8 FL OZ (236 mL)

*This product is not manufactured or distributed by Foundation Consumer Brands, LLC, the distributor of Children's Dimetapp® Cold & cough

Distributed by

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Target Children's Cold & Cough Day & Nighttime Value Pack 236 mLTarget Children's Cold & Cough Day & Nighttime Value Pack 236 mL

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82442-64782442-647-08
82442-40682442-406-04
82442-60782442-607-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
BROMPHENIRAMINE MALEATEIXA7C9ZN03ACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
22772b94-6bde-17fd-e063-6294a90aed1beee190e9-0698-44bf-9399-eb1450378af52024-09-19WarningsExact identifier
spl set id: eee190e9-0698-44bf-9399-eb1450378af5

Reported adverse events (FAERS/openFDA)#

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