TOPCARE CHILDRENS NIGHT TIME COLD AND COUGH- diphenhydramine hydrochloride, phenylephrine hydrochloride solution

topcare childrens night time cold and cough by

Drug Labeling and Warnings

topcare childrens night time cold and cough by is a Otc medication manufactured, distributed, or labeled by Topco Associates 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
• itchy nose or throat
• runny nose
• 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. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
• with any other product containing diphenhydramine, even one used on skin
• to make a child sleepy

Ask a doctor before use if the child 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
• may cause marked drowsiness
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occurs
• symptoms do not get better within 7 days or occur with fever
• cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Keep out of reach of children.

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

Directions

• may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
• use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.

• Age:

  Dose

• children under 4 years of age:

  do not use

• children 4 to under 6 years of age:

  do not use unless

  directed by a doctor

• children 6 to under 12 years of age:

  10 mL

Other information

• each 5 mL contains: sodium 3 mg
• store at 20-25°C (68-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

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COMPARE TO CHILDREN’S TRIAMINIC® NIGHT TIME COLD & COUGH ACTIVE INGREDIENTS

TRIACTING SYRUP

children’s Night Time Cold & Cough

ANTIHISTAMINE – COUGH SUPPRESSANT

DIPHENHYDRAMINE HCl

NASAL DECONGESTANT – PHENYLEPHRINE HCl

Cough Relief

Runny & Stuffy Nose

Itchy Throat

OUR PHARMACISTS RECOMMEND

Ages 6 to under 12 Years

GRAPE FLAVOR

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

TOPCARE CHILDRENS NIGHT TIME COLD AND COUGH 
diphenhydramine hydrochloride, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-859
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-859-26	1 in 1 CARTON	04/16/2019
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 final	part341	04/16/2019

Labeler - Topco Associates LLC (006935977)