ADWE CHILDRENS PAIN FEVER- acetaminophen suspension

ADWE Childrens Pain Fever by

Drug Labeling and Warnings

ADWE Childrens Pain Fever by is a Otc medication manufactured, distributed, or labeled by RARITAN PHARMACEUTICALS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

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

• ▪ Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
• ▪ skin reddening
• ▪ blisters
• ▪ rash

If a skin reaction occurs, stop use and seek medical help right away.

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 is allergic to acetaminophen or any of the inactive ingredients in this product

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 (see overdose warning)

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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children 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 overdose warning)
• shake well before using
• mL = milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• remove the child protective cap and squeeze your child's dose into the dosing cup
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL) **
under 24	under 2 years	ask a doctor
24-35	2-3 years	5 mL
36-47	4-5 years	7.5 mL
48-59	6-8 years	10 mL
60-71	9-10 years	12.5 mL
72-95	11 years	15 mL

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

Other information

• ▪ very low sodium
• ▪ store at room temperature

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

NDC: 68163-695-04

Adwe

Feverx

Children’s Pain+Fever Relief

Acetaminophen
Oral Suspension

PAIN RELIEVER-FEVER REDUCER

Compare to the active ingredient in Children’s Tylenol® Dye-Free Oral Suspension*

For Ages 2-11 Years

• Dye-Free
• No Added Alcohol
• Sugar Free

4 FL. OZ. (120 mL)
160 mg per 5 mL

CHERRY FLAVOR
Naturally Flavored

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributer of Children’s Tylenol® Dye-Free Oral Suspension.

Manufactured for : Adwe Laboratories

1274 49 Street Brooklyn, NY 11219

INGREDIENTS AND APPEARANCE

ADWE CHILDRENS PAIN FEVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-695
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-695-04	1 in 1 PACKAGE	01/17/2022
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/17/2022

Labeler - RARITAN PHARMACEUTICALS INC (127602287)