Label: TARGET CHILDRENS DT AND NT COLD AND COUGH- brompheniramine maleate,dextromethorphan hbr,phenylephrine hcl,diphenhydramine hcl, phenylephrine hcl kit
- NDC Code(s): 82442-464-04, 82442-466-04, 82442-536-08
- Packager: TARGET CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 7, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Children’s Daytime Cold & Cough Active ingredients (in each 10 mL)
- Children’s Nighttime Cold & Congestion Active ingredients (in each 10 mL)
- Purposes for Children’s Daytime Cold & Cough
- Purposes for Children’s Nighttime Cold & Congestion
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Uses
Daytime
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- temporarily relieves
- ▪
- nasal congestion
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- runny nose
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- cough
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- sneezing
- ▪
- itching of the nose or throat
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- itchy, watery eyes due to hay fever
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- temporarily restores freer breathing through the nose.
Nighttime
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- temporarily relieves
- ▪
- nasal congestion
- ▪
- runny nose
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- cough
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- sneezing
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- itching of the nose or throat
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- itchy, watery eyes due to hay fever
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- temporarily restores freer breathing through the nose.
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Warnings Do not use
Daytime
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- to sedate a child or to make a child sleepy
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- 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Nighttime only
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- to sedate a child or to make a child sleepy
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- 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
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- With any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
DAYTIME
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- heart disease
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- high blood pressure
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- diabetes
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- thyroid disease
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
NIGHTTIME
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- heart disease
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- high blood pressure
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- diabetes
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- thyroid disease
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem 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
DAYTIME
- ▪
- taking any other oral nasal decongestant or stimulant
- ▪
- taking sedatives or tranquilizers
NIGHTTIME
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- taking any other oral nasal decongestant or stimulant
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- taking sedatives or tranquilizers
When using this product
Daytime
- ▪
- do not use more than directed.
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- may cause marked drowsiness
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- avoid alcohol, sedatives and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- excitability may occur, especially in children
Nighttime
- ▪
- do not use more than directed.
- ▪
- may cause marked drowsiness
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- avoid alcohol, sedatives and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- excitability may occur, especially in children
Stop use and ask a doctor if
DAYTIME
- ▪
- nervousness, dizziness, or sleeplessness occur
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- symptoms do not get better with 7 days or are accompanied with fever
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- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache.
These could be signs of a serious condition.
NIGHTTIME
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- nervousness, dizziness, or sleeplessness occur
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- symptoms do not get better with 7 days or are accompanied with fever
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- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache.
These could be signs of a serious condition.
- If pregnant or breast-feeding,
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Directions
Daytime
- ▪
- do not take more than 6 doses in any 24-hour period
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- measure only with dosing cup provided.
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- Keep dosage 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 of age
do not use
Nighttime- ▪
- do not take more than 6 doses in any 24-hour period
- ▪
- measure only with dosing cup provided.
- ▪
- Keep dosage 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 of age
do not use
- Other information
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Inactive ingredients
Inactive ingredients for Day Time
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
Inactive ingredients for Nighttime
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, 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*
Children's Daytime
Cold & Cough
Brompheniramine Maleate 2 mg (Antihistamine),
Dextromethorphan HBr 10 mg (Cough Suppressant)
Phenylephrine HCI 5 mg (Nasal Decongestant)
- •
- Sneezing, stuffy or runny nose, cough, itchy or watery eyes
- •
- No added alcohol
Dosing Cup Included
Ages 6+ Years
Grape Flavor
NATURALLY AND ARTIFICIALLY FLAVORED
4 FL OZ (118mL)
Compare to the active ingredients in Children's Dimetapp® Nighttime Cold & Congestion**
Children's Nighttime
Cold & Congestion
Diphenhydramine HCI 12.5 mg (Antihistamine / Cough Suppressant)
Phenylephrine HCI 5 mg (Nasal Decongestant)
- •
- Sneezing, stuffy or runny nose, cough, itchy or watery eyes
- •
- No added alcohol
Dosing Cup Included
Ages 6+ Years
Grape Flavor
NATURALLY AND ARTIFICIALLY FLAVORED
4 FL OZ (118mL)
8 FL OZ (236 mL) TOTAL
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. ALWAYS WAIT AT LEAST 4 HOURS BEFORE TAKING ANOTHER DOSE OF THE PRODUCT.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING
IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE FOR FULL LABELING
*This product is not manufactured or distributed by Foundation Consumer Brands, LLC, the distributor of Children's Dimetapp® Cold & Congestion.
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Distributed by: Target Corporation
Minneapolis, MN 55403
Made in the U.S.A. with domestic and imported ingredients
TM & ©2024 Target Brands, Inc,
- Product Label
-
INGREDIENTS AND APPEARANCE
TARGET CHILDRENS DT AND NT COLD AND COUGH
brompheniramine maleate,dextromethorphan hbr,phenylephrine hcl,diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82442-536 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82442-536-08 1 in 1 KIT; Type 0: Not a Combination Product 06/14/2024 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 TGT CHILDRENS DAYTIME COLD AND COUGH
brompheniramine maleate, dextromethorphan hbr,phenylephrine hcl liquidProduct Information Item Code (Source) NDC:82442-464 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82442-464-04 118 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 Drug M012 06/14/2024 Part 2 of 2 TGT CHILDRENS NIGHTTIME COLD AND COUGH
diphenhydramine hcl,phenylephrine hcl liquidProduct Information Item Code (Source) NDC:82442-466 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82442-466-04 118 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 Drug M012 06/14/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/14/2024 Labeler - TARGET CORPORATION (006961700)