CHILDRENS NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl liquid

Childrens Nighttime Cold and Cough by

Drug Labeling and Warnings

Childrens Nighttime Cold and Cough by is a Otc medication manufactured, distributed, or labeled by KinderFarms, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

Antihistamine/

Cough suppressant

Nasal decongestant

Uses

temporarily relieves:

• sneezing
• runny nose
• itchy nose or throat
• itchy, watery eyes due to hay fever
• nasal and sinus congestion
• cough due to minor throat and bronchial irritation as may occur with a cold

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
  

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

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
  

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or occur with a fever
• cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition.

Keep out of reach of children.

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

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

Other information

• store between  20-25º (68-77ºF)
• do not refrigerate
• protect from light
  

Inactive ingredients

Organic agave syrup, non-GMO citric acid, organic natural flavors, purified water

QUESTIONS?

 Call 424-235-0355

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

KINDERMED Kids Nighttime Cold & Cough Cherry Flavor

INGREDIENTS AND APPEARANCE

CHILDRENS NIGHTTIME COLD AND COUGH 
diphenhydramine hcl, phenylephrine hcl liquid

Product 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)