Label: CHILDRENS NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl liquid
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- NDC Code(s): 82673-103-04
- Packager: KinderFarms, LLC
- 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 May 31, 2022
If you are a consumer or patient please visit this version.
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- Active ingredients (in each 5 mL)
- Purposes
- Uses
-
Warnings
Do not use
- in a child under 4 years of age
- in a child who is 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 contains an MAOI, ask a doctor or pharmacist before giving this product.
- with any other product containing diphenhydramine, even one used on skin
- for the purpose of making your child sleepy
Ask a doctor before use if the chld has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
- a breathing problem such as chronic bronchitis
When using this product
-
do not exceed recommended dosage
- marked drowsiness may occur
- excitability may occur, especially in children
- sedatives and tranquilizers may increase drowsiness
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Directions
- do not take more than 6 doses in any 24-hours unless directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL= milliliter
- shake well before using
age dose children 6 to under12 years of age
10 mL every 4 hours children 4 to under 6 years of age
do not use unless directed by a doctor children under 4 years of age
do not use - do not take more than 6 doses in any 24-hours unless directed by a doctor
- Other information
- Inactive ingredients
- QUESTIONS?
-
Principal Display Panel
KIDS NIGHTTIME COLD & COUGH Age 6-11 yrs
Diphenhydramine HCl 6.25 mg per 5 mL
Antihistamine/ Cough Suppressant
Phenylephrine HCl 2.5 mg per 5 mL
Nasal Decongestant
Organic Cherry Flavor
NO COMMON ALLERGENS.
NO DYES OR PARABENS.
DOSING CUP INCLUDED
FL OZ (mL)
TAMPER EVIDENT: BOTTLE IS SAFETY SEALED. DO NOT USE IF BOTTLE SEAL IS BROKEN OR MISSING.
Keep outer carton for complete warnings and product information.
DISTRIBUTED BY: KinderFarms®
Redondo Beach, CA 90277 USA
kinderfarms.com
- Package Label
-
INGREDIENTS AND APPEARANCE
CHILDRENS NIGHTTIME COLD AND COUGH
diphenhydramine hcl, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82673-103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 6.25 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength AGAVE TEQUILANA JUICE (UNII: GVG8G0207O) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82673-103-04 1 in 1 BOX 04/29/2022 1 118 mL in 1 BOTTLE; 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 04/29/2022 Labeler - KinderFarms, LLC (075458767)
