ADWE CHILDRENS PAIN FEVER- acetaminophen suspension 
RARITAN PHARMACEUTICALS INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ADWE Children’s Pain+Fever Relief

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

ADWE Children's Pain+ Fever Relief Acetaminophen Oral Suspension
ADWE CHILDRENS PAIN FEVER 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-695
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-695-041 in 1 PACKAGE01/17/2022
1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/17/2022
Labeler - RARITAN PHARMACEUTICALS INC (127602287)

Revised: 8/2023
Document Id: 339b0dcb-1efb-4dd7-b2d7-aea86734e633
Set id: 79a3232f-0211-4c8a-acee-4f87e06ffc26
Version: 3
Effective Time: 20230816
 
RARITAN PHARMACEUTICALS INC