Childrens Pain and Fever Acetaminophen description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Pain and Fever Acetaminophen

Rugby

Children's Pain & Fever Acetaminophen Oral Suspension


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain Reliever / Fever Reducer

Childrens Pain and Fever Acetaminophen Uses

temporarily reduces fever and relieves minor aches and pains caused by

  • headache
  • common cold
  • flu
  • toothache
  • sore throat

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, lasts for more than 2 days or 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.

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

When using this product, do not exceed recommended dose

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
  • redness or swelling is present
  • any new symptoms appear

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 (1-800-222-1222) right away. Prompt 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
  • shake well before using
  • if possible, use weight to dose; otherwise use age
  • use only with enclosed syringe. Do not use with any other dosing device
  • push air out of syringe. Firmly push syringe into bottle opening.
  • turn bottle upside-down and pull syringe to the correct dose
  • dispense liquid slowly into child's mouth, towards inner cheek
  • give dose every 4 hours while symptoms last
  • do not give more than 5 doses in 24 hours

24-35 lbs (2-3 years): 5 mL

Under 24 lbs (under 2 years): ask a doctor

Childrens Pain and Fever Acetaminophen Other information

store at at 20°-25° C (68°-77° F)

Inactive ingredients

Artificial flavor, citric acid anhydrous, corn syrup, FD&C Red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

Call 1-800-645-2158
9 am-5 pm ET, Monday-Friday

Pain & Fever Acetaminophen Oral Suspension is distributed by Rugby Laboratories, Inc.

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

NDC 0536-3606-96
ASPIRIN & ALCOHOL FREE

COMPARE TO
ACTIVE INGREDIENT IN
INFANTS' TYLENOL
® *

Rugby ®

RELIEVES CHILDREN'S
Pain
& Fever

Acetaminophen Oral Suspension
160 mg/5 mL
Pain Reliever - Fever Reducer
CHERRY FLAVORED
2 fl oz (60 mL)

See New
Dosing Directions

For use with
enclosed
syringe

• SATISFACTION GUARANTEED •
Rugby
OR YOUR MONEY BACK

Childrens Pain and Fever Acetaminophen

Childrens Pain and Fever Acetaminophen

Acetaminophen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-3606
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
CHERRY
CITRIC ACID MONOHYDRATE
CORN SYRUP
GLYCERIN
cellulose, microcrystalline
CARBOXYMETHYLCELLULOSE SODIUM
propylene glycol
water
SODIUM BENZOATE
Sucralose
sorbitol
XANTHAN GUM
FD&C RED NO. 40

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-3606-96 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-08-24


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