HEALTHY ACCENTS MULTI SYMPTOM COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension

healthy accents multi symptom cold by

Drug Labeling and Warnings

healthy accents multi symptom cold by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves the following cold/flu symptoms:
• minor aches and pains
• headache
• sore throat
• cough
• stuffy nose
• sneezing and runny nose
• 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

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

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

Ask a doctor before use if the child has

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

Ask a doctor or pharmacist before use if the child is

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

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

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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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 Liver warning)
• shake well before using
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• if needed, repeat dose every 4-6 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give for more than 5 days unless directed by a doctor

Weight (lb)	Age (yr)	Dose (tsp or mL)
under 36 lbs	under 4 years	do not use
36-47 lbs	4-5 years	do not use unless directed by a doctor
48-95 lbs	6-11 years	2 tsp or 10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

• each teaspoon contains: sodium 3 mg
• store between 20-25°C (68-77°F)
• do not use if printed neckband is broken or missing

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?

1-866-322-2439

Principal Display Panel

children's

pain relief plus

multi-symptom cold

Fever Reducer - Pain Reliever - Antihistamine

Cough Suppressant - Nasal Decongestant

fever & sore throat (acetaminophen)

cough (dextromethorphan HBr)

stuffy nose (phenylephrine HCl)

sneezing & runny nose (chlorpheniramine maleate)

Compare to Children's Tylenol® Plus Multi-Symptom Cold active ingredients

grape flavor

alcohol free - oral suspension

Multi-Symptom Cold Carton Image 1

Multi-Symptom Cold Carton Image 1

Multi-Symptom Cold Carton Image 2

INGREDIENTS AND APPEARANCE

HEALTHY ACCENTS MULTI SYMPTOM COLD 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-903
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: 55316-903-26	1 in 1 CARTON	06/06/2011
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	06/06/2011

Labeler - DZA Brands LLC (090322194)