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plus multi symptom cold

Hannaford Brothers Company

Hannaford Bros. Co. Children's Pain Relief Plus Multi-Symptom Cold Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (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

plus multi symptom cold Uses

  • temporarily relieves the following cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • cough
  • nasal congestion
  • 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

  • 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 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

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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

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

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • 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. If possible, use weight to dose; otherwise use age.
  • use only with enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4-6 hours
  • do not give more than 5 times in 24 hours
Weight(lb) Age(yr) Dose (tsp or mL)
under 36 under 4 do not use
36-47 4-5 do not use unless directed by a doctor
48-95 6-11 2 tsp or 10 mL

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

plus multi symptom cold Other information

  • each teaspoon contains: sodium 3 mg
  • store at 20º-25ºC (68º-77ºF)
  • do not use if printed neckband is broken or missing

Inactive ingredients

carrageenan, citric acid, D&C red no. 33, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

Questions or comments?

1-800-213-9040

Principal Display Panel

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

Fever Reducer/Pain Reliever

Cough Suppressant

Nasal Decongestant

Antithistamine

See New Warnings Information

Children’s Pain Relief

Plus Multi-Symptom Cold

Contains 4 Ingredients:

Fever & Sore Throat – Acetaminophen

Cough – Dextromethorphan HBr

Stuffy Nose – Phenylephrine HCl

Sneezing & Runny Nose – Chlorpheniramine Maleate

Grape Flavor

Oral Suspension

plus multi symptom cold
Children's Pain Relief Plus Multi-Symptom Cold Carton Image 1 Children's Pain Relief Plus Multi-Symptom Cold Carton Image 2

plus multi symptom cold

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41268-903
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
CARRAGEENAN
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
polysorbate 80
water
SODIUM BENZOATE
sorbitol
SUCROSE
XANTHAN GUM

Product Characteristics

Color
PURPLE (opaque)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:41268-903-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-10-29


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Be sure to consult your doctor before taking any medication!
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