Label: NIGHTTIME COLD AND COUGH- diphenhydramine hcl liquid
- NDC Code(s): 82673-191-04
- Packager: KinderFarms, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 14, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL)
- Purposes
-
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
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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
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
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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
- Other information
- QUESTIONS?
-
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
- Package Label
-
INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND COUGH
diphenhydramine hcl liquidProduct 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)
