CHILDRENS PAIN AND FEVER- acetaminophen solution

Childrens Pain and Fever by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

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 acetamintophen.
Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.
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.

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 

 for more than 10 days for pain unless directed by a doctor

 for more than 3 days for fever unless directed by a doctor

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 last more than 5 days

 fever gets worse or last 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. Quick medical attention is critical even if you do not notice any signs or symptoms. (1-800-222-1222)

Directions

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.

 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

this product does not contain directions or complete warnings for adult use.

How to Open & Use:

1. Flick the tip before opening so liquid descends.
2. Twist the tip until open and discard immediately.
3. Place open end into child’s mouth and Squeeze to dispense all liquid and discard.

                                                                                    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) Every 4 hours while symptoms last. Do not exceed 5 Single-Use Vials in 24 hours.

Other Information

• each Single-Use Vial contains 6mg of sodium
• store at 20-25ºC (68-77ºF)
• 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?

+1-954-721-5000 Mon – Fri 9am to 6pm EST

Package Labeling:

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN AND FEVER 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70302-011
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70302-011-20	20 in 1 BOX	11/01/2018
1		5 mL in 1 VIAL, SINGLE-USE; 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	11/01/2018

Labeler - Unipharma, LLC (079524332)

Establishment
Name	Address	ID/FEI	Business Operations
Unipharma, LLC		079524332	manufacture(70302-011)