SMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension

smart sense multi symptom fever and cold by

Drug Labeling and Warnings

smart sense multi symptom fever and cold by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves
• minor aches and pains
• headache
• minor sore throat pain
• runny nose
• itchy nose or throat
• sneezing
• 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
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• in a child under 4 years of age
• if your child has ever had an allergic reaction to this product or any of its ingredients
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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.
• to make a child sleepy

Ask a doctor before use if your child has

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

Ask a doctor or pharmacist before use your child is taking

• sedatives or tranquilizers
• the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage
• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• pain, nasal congestion or cough gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see Overdose warning)
• shake well before using
• remove the child protective cap and squeeze your child’s dose into the dosing cup
• may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
• use enclosed dosing cup only. Keep for use with this product. 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
• contains no aspirin
• store at 20-25°C (68-77°F). Protect from light.
• close cap tightly

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO ACTIVE INGREDIENTS IN CHILDREN’S TRIAMINIC®

MULTI-SYMPTOM FEVER & COLD

FOR AGES 6-11 YEARS

children’s multi-symptom fever & cold

ORAL SUSPENSION

ACETAMINOPHEN (PAIN RELIEVER/FEVER REDUCER)

CHLORPHENIRAMINE MALEATE (ANTIHISTAMINE)

DEXTROMETHORPHAN HBr (COUGH SUPPRESSANT)

PHENYLEPHRINE HCl (NASAL DECONGESTANT)

GRAPE FLAVOR

RELIEVES:

PAIN – FEVER – STUFFY NOSE – COUGH – SNEEZING – RUNNY NOSE

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

SMART SENSE MULTI SYMPTOM FEVER AND COLD  CHILDRENS
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CARRAGEENAN (UNII: 5C69YCD2YJ)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CALCIUM SULFATE (UNII: WAT0DDB505)
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-011-26	1 in 1 CARTON	10/23/2015
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	10/23/2015

Labeler - Kmart Corporation (008965873)