HEALTHY ACCENTS CHILDRENS MULTI SYMPTOM FEVER AND COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
healthy accents childrens multi symptom fever and cold by
Drug Labeling and Warnings
healthy accents childrens multi symptom fever and 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)
- Purposes
- Uses
-
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.
-
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 4-6 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
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to Children’s Triaminic® Suspension Multi-Symptom Fever & Cold active ingredients
children’s multi - symptom fever & cold
acetaminophen (pain reliever/fever reducer)
chlorpheniramine maleate (antihistamine)
dextromethorphan HBr (cough suppressant)
phenylephrine HCl (nasal decongestant)
triacting suspension
cold & flu symptom relief
runny & stuffy nose
aches & pains
fever – cough
sore throat
for ages 6 to under 12 years
grape flavor
4 FL OZ (118mL)
alcohol free – aspirin free
NO GLUTEN
-
INGREDIENTS AND APPEARANCE
HEALTHY ACCENTS CHILDRENS MULTI SYMPTOM FEVER AND COLD
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 55316-005 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: 55316-005-26 1 in 1 CARTON 10/22/2015 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 10/22/2015 Labeler - DZA Brands LLC (090322194)
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