Nighttime Cold and Cough by KinderFarms, LLC Drug Facts

Drug Details [pdf]

NIGHTTIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl liquid
KinderFarms, LLC

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Drug Facts

Active ingredients (in each 5 mL)

Diphenhydramine HCl 6.5 mg

Phenylephrine HCl 2.5

Purposes

Antihistamine/

Cough suppressant

Nasal Decongestant

Uses

temporarily relieves:

sneezing
runny nose
itchy nose or throat
itchy, watery eyes due to hay fever or other upper respiratory allergies
the impulse to cough
cough to help you get to sleep
cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritant
the intensity of coughing

Warnings

Do not use

in a child under 4 years of age
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

glaucoma
cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
diabetes
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

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
alcohol, sedatives and tranquilizers may increase drowsiness effect
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breat-feeding,

ask a health professional before use.

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

adults and children 6 years and over: do not exceed 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
shake well before using
mL= milliliter

Age	Dose
adults and children 12 years of age and over	10 mL every 4 hours
children 6 to under 12 years of age	5 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

Inactive ingredients

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

Other information

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

QUESTIONS?

Call 424-235-0355

Principal Display Panel

KIDS' Ages 6+

NIGHTTIME

COLD & COUGH

Diphenhydramine HCl 12.5 mg per 5 mL

Antihistamine/Cough Suppressant

Organic Cherry Flavor

DOSING CUP INCLUDED

FL OZ (mL)

TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING

DISTRIBUTED BY: KinderFarms®

Redondo Beach, CA 90277 USA

kinderfarms.com

Package Label

KINDERMED kIDS Nighttime Cold & Cough Cherry Flavor

NIGHTTIME COLD AND COUGH
diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82673-190
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
MALTITOL (UNII: D65DG142WK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 82673-190-04	1 in 1 BOX	12/31/2023	03/12/2024
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	12/31/2023	03/12/2024

Labeler - KinderFarms, LLC (075458767)

Revised: 3/2024

Document Id: f8f14497-7968-4aeb-aacd-caeacfe6bced

Set id: 9e523340-8b0d-412f-8974-611c939c980f

Version: 6

Effective Time: 20240312