Smart Sense Childrens Nighttime Cold and Cough description, usages, side effects, indications, overdosage, supplying and lots more!

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Smart Sense Childrens Nighttime Cold and Cough

Kmart Corporation

Kmart Corporation Children’s Nighttime Cold & Cough Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 5 mL, 1 teaspoon)

Diphenhydramine HCl, USP 6.25 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Antihistamine/cough suppressant

Nasal decongestant

Smart Sense Childrens Nighttime Cold and Cough Uses

  • •temporarily relieves
  • •itchy, watery eyes due to hay fever
  • •sneezing
  • •nasal and sinus congestion
  • •runny nose
  • •itchy nose or throat
  • •cough due to minor throat and bronchial irritation

Warnings

Do not use

  • •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

  • •high blood pressure
  • •thyroid disease
  • •glaucoma
  • •diabetes
  • •heart disease
  • •cough that occurs with too much phlegm (mucus)
  • •a breathing problem such as chronic bronchitis
  • •cough that lasts or is chronic such as occurs with asthma

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 lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. 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

  • •take every 4 hours; not to exceed 6 doses in 24 hours or as directed by a doctor

children 6 to under 12 years of age

2 teaspoons (tsp)

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

Smart Sense Childrens Nighttime Cold and Cough Other information

  • •each teaspoon contains: sodium 3 mg
  • •store at 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients of Children’s Triaminic® Night Time Cold & Cough Syrup

For Ages 6 to 12

COLD & COUGH

Children’s Nighttime Cold & Cough

ANTIHISTAMINE/COUGH SUPPRESSANT, (Diphenhydramine HCl)

NASAL DECONGESTANT, (Phenylephrine HCl)

Grape Flavor

RELIEVES:

Cough

Runny, Stuffy Nose

Itchy Throat

4 FL OZ (118 mL)

Smart Sense Childrens Nighttime Cold and Cough

Diphenhydramine HCl, Phenylephrine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49738-453
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 6.25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
propylene glycol
water
SODIUM BENZOATE
SODIUM CITRATE

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:49738-453-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-04-18


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Be sure to consult your doctor before taking any medication!
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