Childrens Plus Cough and Runny Nose description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Plus Cough and Runny Nose

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Aaron Industries, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg

Purposes

Acetaminophen.......................................Pain reliever/fever reducer
Chlorpheniramine maleate.....................Antihistamine
Dextromethorphan HBr..........................Cough suppressant

Childrens Plus Cough and Runny Nose Uses

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

• 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.
• with any other drug containing acetaminophen
(prescription or non-prescription). If you are not
sure whether a drug contains acetaminophen,
ask a doctor or pharmacist.

Ask a doctor before use if the child has

• 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 • liver disease

Ask a doctor or pharmacist before use if the child is taking

• sedatives or tranquilizers
• the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage
(see overdose warning)

• may cause excitability, especially in children
• marked drowsiness may occur
• sedatives and tranquilizers may increase
drowsiness

Stop use and ask a doctor if

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

Keep this and all drugs out of the reach of children.

Overdose Warning: Taking more than the
recommended dose (overdose) could cause serious
health problems, including liver damage. In case of
accidental overdose, seek professional assistance or
contact a Poison Control Center immediately.
Quick medical attention is critical even if you do not
notice any signs or symptoms.

Directions

• do not exceed recommended dosage
(see overdose warning) • do not use in infants
• shake well before using
• find right dose on chart below. If possible, use
weight to dose; otherwise, use age
• if needed, repeat dose every 4 hours while
symptoms last
• 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 unlessdirected by a doctor
48-95                               6-11                            2 tsps or 10 mL

Other Information

• dosage cup provided
• store at controlled room temperature

Inactive Ingredients

acesulfame potassium, carboxymethylcellulose sodium,
cellulose, citric acid, flavors, glycerin, high fructose corn syrup,
purified water, red 33, red 40, sodium benzoate, sorbitol,
xanthan gum

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Childrens Plus Cough and Runny Nose

Cherry Flavor

Oral Suspension

4 FL OZ (118 mL)

Childrens Plus Cough and Runny Nose

Childrens Plus Cough and Runny Nose

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63941-130
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

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
CARBOXYMETHYLCELLULOSE SODIUM
cellulose, microcrystalline
CITRIC ACID MONOHYDRATE
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
water
D&C RED NO. 33
FD&C RED NO. 40
SODIUM BENZOATE
sorbitol
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63941-130-04 118 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-03-03


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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