AUROPHEN INFANTS PAIN AND FEVER- acetaminophen suspension

Aurophen Infants Pain and Fever by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen, USP 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.
• for more than 10 days for pain unless directed by a doctor.
• for more than 3 days for fever unless directed by a doctor.
• 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 using and ask a doctor if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse

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). Prompt 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. If possible, use weight to dose; otherwise, use age.
• use only enclosed syringe designed for use with this product. Do not use any other dosing device.
• remove bottle cap and insert syringe tip through opening at top of the bottle
• tip bottle upside down and draw medicine into the syringe
• fill to dose level
• dispense liquid slowly into child’s mouth, toward inner cheek
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL)*
* or as directed by a doctor
under 24	under 2 years	ask a doctor
24-35	2-3 years	5 mL

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

Other information

• each 5 mL contains: sodium 6 mg
• store at 20°-25°C (68°-77°F)
• do not use if printed bottle body wrap is broken or missing
• see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-855-274-4122

Distributed by: Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 1 FL OZ (30 mL)

AUROHEALTH
NDC: 58602-203-07
Compare to Infants’
TYLENOL® Oral Suspension
active ingredient**
AUROPHEN
INFANTS’ PAIN & FEVER
SUSPENSION LIQUID
ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL
Pain Reliever & Fever Reducer
- Alcohol Free
- Aspirin Free
- Ibuprofen Free
- Gluten Free
Dye-Free
Grape Flavor
Use ONLY enclosed syringe
1 FL OZ (30 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 2 FL OZ (59 mL)

AUROHEALTH
NDC: 58602-203-11
Compare to Infants’
TYLENOL® Oral Suspension
active ingredient**
AUROPHEN
INFANTS’ PAIN & FEVER
SUSPENSION LIQUID
ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL
Pain Reliever & Fever Reducer
- Alcohol Free
- Aspirin Free
- Ibuprofen Free
- Gluten Free
Dye-Free
Grape Flavor
Use ONLY enclosed syringe
2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

AUROPHEN INFANTS PAIN AND FEVER 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-203
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)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GRAPE (UNII: 6X543N684K)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (White to off-white)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-203-07	1 in 1 CARTON	04/30/2015
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-203-11	1 in 1 CARTON	04/30/2015
2		59 mL in 1 BOTTLE; 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	04/30/2015

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-203)