Label: DAYTIME COLD AND COUGH AND NIGHTTIME COLD AND CONGESTION CHILDRENS- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl kit
- NDC Code(s): 0363-4590-08
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 21, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients for Nighttime (in each 10 mL)
- Active ingredients for Daytime (in each 10 mL)
- Purpose for Nighttime
- Purpose for Daytime
-
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
-
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
-
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?
-
Principal Display Panel
Compare to the active ingredients in Children's Dimetapp® Cold & Cough & Nighttime Cold & Congestion††
Children's Cold & Congestion Relief
DIPHENHYDRAMINE HCl 12.5 mg /
ANRIHISTAMINE / COUGH SUPPRESSANT
PHENYLEPHRINE HCl 5 mg /
NASAL DECONGESTANT
Nighttime
Alcohol Free
- Relieves stuffy nose, runny nose, sneezing, itchy & watery eyes & coughing
AGES 6 YEARS & OLDER
Grape flavor
DOSING CUP INCLUDED
AGES 6 + YEARS
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
Children's Cold & Cough Relief
BROMPHENIRAMINE MALEATE 2 mg
ANTIHISTAMINE
DEXTROMETHORPHAN HBr 10 mg /
COUGH SUPPRESSANT
PHENYLEPHRINE HCI 5 mg /
NASAL DECONGESTANT
Daytime
Alcohol Free
- Relieves nasal congestion, runny nose, itchy & watery eyes, sneezing & coughing
AGES 6 YEARS & OLDER
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: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME COLD AND COUGH AND NIGHTTIME COLD AND CONGESTION CHILDRENS
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4590 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-4590-08 1 in 1 KIT; Type 0: Not a Combination Product 03/04/2022 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 liquidProduct Information Item Code (Source) NDC:0363-3130 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) MALTITOL (UNII: D65DG142WK) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/04/2022 Part 2 of 2 DAYTIME COLD AND COUGH CHILDRENS
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Item Code (Source) NDC:0363-4580 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 2 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/04/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/04/2022 Labeler - Walgreens (008965063)
