Label: CHILDRENS NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl liquid
- NDC Code(s): 82673-103-04
- Packager: KinderFarms, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 10, 2024
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- Official Label (Printer Friendly)
- 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
-
Directions
- do not give 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 give 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. SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED 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 Drug M012 04/29/2022 Labeler - KinderFarms, LLC (075458767)
