Daytime Cold and Cough and NightTime Cold and Congestion Childrens: Package Insert and Label Information

DAYTIME COLD AND COUGH AND NIGHTTIME COLD AND CONGESTION CHILDRENS- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl
TARGET Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients for Nighttime (in each 10 mL)

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg

Active ingredients for Daytime (in each 10 mL)

Brompheniramine Maleate 2 mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5 mg

Purpose for Nighttime

Antihistamine / Cough suppressant

Nasal Decongestant

Purpose for Daytime

Antihistamine

Cough suppressant

Nasal decongestant

Uses

Nighttime

  • temporarily relieves these symptoms occuring with a cold, hay fever, or other upper respiratory allergies
  • nasal congestion
  • cough
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Daytime

  • temporaily relieves cough due to minor throat and bronchial irritation occuring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis)
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily restores freer breathing through the nose

Warnings

Do not use

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,psychiatic 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

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

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

Nighttime

  • 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
  • excitablity may occur, especially in children

Daytime

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

Nighttime

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with a 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,

Nighttime

ask a health professional before use.

Daytime

ask a health professional before use

Keep out of reach of children.

Nighttime

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

Daytime

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

Directions

Nighttime

  • do not take more than 6 doses in any 24 hours period
  • do not exceed recommended dosage
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL = mililiter
Age Dose
adults and children 12 years and over 20 mL every 4 hours
childen 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. Do not use any other dosing dosing device.
  • keep dosing cup with product
  • mL = mililiter
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

Nighttime

  • each 10 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF)
  • do not refrigerate
  • protect from light

Daytime

  • each 10 mL contains: 5 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

Nighttime

acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C Blue #1, FD&C red #40, Flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

Daytime

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions or comments?

Nighttime

Call 1-800-910-6874

Daytime

Call 1-800-910-6874

Principal Display Panel

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

Children’s night time

Cold & Congestion

Diphenhydramine HCI 12.5 mg (Antihistamine-Cough Suppressant)

Phenylephrine HCI 5 mg (Nasal Decongestant)

stuffy nose

runny nose

sneezing

itchy,watery eyes

cough

GRAPE FLAVOR

DOSING CUP INCLUDED

AGES 6 + YEARS

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

**This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children’s Dimetapp® Nighttime Cold & Congestion.

DAYTIME

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

children’s day time

Cold + Cough

Brompheniramine Maleate 2 mg (Antihistamine)

Dextromethorphan HBr 10 mg (Cough Suppressant)

Phenylephrine HCI 5 mg (Nasal Decongestant)

cough

itchy, watery eyes

runny nose

sneezing

stuffy nose

itchy of the nose or throat

alcohol free

GRAPE FLAVOR

DOSING CUP INCLUDED

AGES 6 + YEARS

GRAPE FLAVOR

FL OZ (mL)

* This product is not manufactured or distributed by Pfizer Consumer Healthcare, Distributor of Children’s Dimetapp® Cold & Cough.

Distributed by Target Corporation

Minneapolis, MN 55403

©2015 Target Brands, Inc.

Product Label

Diphenhydramine HCI 12.5 mg, Phenylephrine HCI 5 mg, Brompheniramine HBr 10 mg, Dextromethorphan HBr10 mg, Phenylephrine HCI 5 mg
(click image for full-size original)

TARGET Children’s Nighttime Cold and Congestion Children’s Daytime Cold and Cough

DAYTIME COLD AND COUGH AND NIGHTTIME COLD AND CONGESTION CHILDRENS
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-059
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11673-059-08 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 118 mL
Part 2 1 BOTTLE, PLASTIC 118 mL
Part 1 of 2
NIGHT TIME COLD AND CONGESTION CHILDRENS
diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Item Code (Source) NDC:11673-058
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
PROPYLENE GLYCOL
WATER
FD&C RED NO. 40
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
MALTITOL
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11673-058-04 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/31/2015
Part 2 of 2
DAYTIME COLD AND COUGH CHILDRENS
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Item Code (Source) NDC:11673-613
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 2 mg in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
PROPYLENE GLYCOL
WATER
SORBITOL
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
SODIUM BENZOATE
SUCRALOSE
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11673-613-04 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/31/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/31/2015
Labeler — TARGET Corporation (006961700)

Revised: 11/2022 TARGET Corporation

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