care one pain relief description, usages, side effects, indications, overdosage, supplying and lots more!

care one pain relief

American Sales Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
American Sales Company Children's Pain Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

  • •reduces fever
  • •relieves minor aches and pains due to:
  • •the common cold
  • •flu
  • •headache
  • •sore throat
  • •toothache

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.
  • •if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has

liver disease

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • •pain gets worse or lasts more than 5 days
  • •fever gets worse or lasts more than 3 days
  • •new symptoms occur
  • •redness or swelling is present

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 enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • •if needed, repeat dose every 4 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 24

under 2 years

ask a doctor

24-35

2–3 years

1 tsp or 5 mL

36–47

4–5 years

1 1/2 tsp or 7.5 mL

48–59

6–8 years

2 tsp or 10 mL

60-71

9–10 years

2 1/2 tsp or 12.5 mL

72-95

11 years

3 tsp or 15 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 at 20°-25°C (68°-77°F)
  • •do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, blue #1, butylparaben, calcium sulfate, carrageenan, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, red #33, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Children’s Tylenol® Oral Suspension

CHILDREN'S

PAIN RELIEF

Fever Reducer/Pain Reliever

Acetaminophen Oral Suspension

Suspension Liquid

GRAPE FLAVOR

AGES 2-11

Alcohol Free

Aspirin Free

Ibuprofen Free

80 mg per 1/2 teaspoon (160 mg per 5 ml)

4 FL OZ (118 ml)

care one pain relief

Acetaminophen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-130
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
BUTYLPARABEN
CALCIUM SULFATE
CARRAGEENAN
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
cellulose, microcrystalline
CARBOXYMETHYLCELLULOSE SODIUM
propylene glycol
water
D&C RED NO. 33
SODIUM BENZOATE
sorbitol
SODIUM PHOSPHATE, TRIBASIC

Product Characteristics

Color
PURPLE (viscous)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 147 in 1 BOTTLE
3 NDC:41520-130-28 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2004-04-13


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