Childrens Plus Cough and Sore Throat description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Plus Cough and Sore Throat

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Aaron Industries, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 160 mg

Dextromethorphan HBr 5mg

Purpose

Pain reliever/fever reducer

Cough Suppressant

Childrens Plus Cough and Sore Throat Uses

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

Warnings

Sore throat warning Severe or persistent sore throat
or sore throat accompanied by fever, headache,
nausea, and vomiting may be serious. Consult
physician promptly. Do not use more than 2 days or
administer to children under 2 years of age unless
directed by a physician.

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 acetaminophen containing
products. This may lead to an overdose, which
may cause liver damage. (see overdose warning)

Ask a doctor before use if the child has

• chronic cough that lasts as occurs with asthma
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child

is taking the blood thinning drug warfarin.

When using this product

• do not exceed recommended dosage
(see overdose warning)

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
• nervousness, dizziness or sleeplessness occurs
• 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 out of reach of children.

Enter section text here

Overdose Warning

Taking more than the
recommended dose (overdose) could cause serious
health problems, including liver damage. In case of
overdose, get medical help or contact the Poison
Control Center right away. 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
• 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 24     under 2           ask a doctor
24-47         2-5                 1 teaspoon or 5 mL
48-95         6-11               2 teaspoons or 10 mL

Childrens Plus Cough and Sore Throat 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 Sore Throat

Cherry Flavor

Oral Suspension

4 FL OZ (118 mL)

Childrens Plus Cough and Sore Throat

Childrens Plus Cough and Sore Throat

Acetaminophen, DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63941-124
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 160 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM BENZOATE
ACESULFAME POTASSIUM
CARBOXYMETHYLCELLULOSE SODIUM
cellulose, microcrystalline
CITRIC ACID MONOHYDRATE
GLYCERIN
water
sorbitol
XANTHAN GUM
FD&C BLUE NO. 1
D&C RED NO. 33

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63941-124-04 118 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-08-13


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