NIGHTTIME COLD AND COUGH- diphenhydramine hcl liquid

Nighttime Cold and Cough by

Drug Labeling and Warnings

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 12.5 mg

Purposes

Antihistamine/

Cough suppressant

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

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 flavor, purified water

QUESTIONS?

Call 424-235-0355

Principal Display Panel

KIDS' Ages 6 yrs+.

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.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: KinderFarms®

Redondo Beach, CA 90277 USA

Package Label

KINDERMED Kids Nighttime Cold & Cough Organic Cherry Flavor

INGREDIENTS AND APPEARANCE

NIGHTTIME COLD AND COUGH 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82673-191
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 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: 82673-191-04	1 in 1 BOX	05/30/2024
1		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	05/30/2024

Labeler - KinderFarms, LLC (075458767)