CHILDRENS PAIN AND FEVER- acetaminophen 160mg/5ml solution

Childrens Pain and Fever by

Drug Labeling and Warnings

Childrens Pain and Fever by is a Otc medication manufactured, distributed, or labeled by CalmCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each 5mL)

Acetaminophen, 160mg

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 for this product. 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.

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). Prompt medical attention is critical even if you do not notice any signs or symptoms.

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

Directions

this product does not contain directions or complete warnings for adult use.
do not give more than directed (see overdose warning)
use the chart below to confirm dose. If possible, use weight to confirm, otherwise use age
give the recommended number of vials below following the instructions under "Easy to Use" on the side panel.
empty each Single-Use Vial required of all liquid when dosing
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

Dosing Chart

Weight (lbs)	Age (Years)	Dose (mL)
under 24 lbs	under 2 years	Talk to a doctor
24 -35 lbs	2 - 3 years	1 Single-Use Vial (5 mL)
36 - 47 lbs	4-5 years	Talk to a doctor
48 - 71 lbs	6-10 years	2 Single-Use Vial (10 mL)
72 - 95 lbs	11 years	3 Single-Use Vial (15 mL)

Other information

• each Single-Use vial contains 8mg of sodium
• store at 68-77ºF (20-25ºC)
• tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken

Inactive ingredients

citric acid, cherry flavor, edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.

Questions or Comments?

+1 941-202-3270 or visit www.DrKids.com

Package

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN AND FEVER 
acetaminophen 160mg/5ml solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-2016(NDC:70302-126)
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
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MALTITOL (UNII: D65DG142WK)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-2016-1	20 in 1 CARTON	11/16/2022
1		5 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/16/2022

Labeler - CalmCo LLC (079308308)

Registrant - CalmCo LLC (079308308)