Acetaminophen by Cardinal Health ACETAMINOPHEN solution

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Acetaminophen...........................160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

temporarily:

• reduces fever
• relieves minor aches and pains due to:
  • the common cold
  • immunizations
  • flu
  • sore throat
  • headache
  • 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 of 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

• symptoms do not improve
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical 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).
• mL = milliliter; tsp = teaspoon
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• repeat dose every 4 hours while symptoms last.
• do not give more than 5 times in 24 hours.

Weight (1lbs.)	Age (yrs.)	Dose (tsp or mL)*
under 24	under 2	ask a doctor
24-35	2-3 years	1 tsp or 5 mL
36-47	4-5 years	1 1/2 tsp or 7.5 mL
48-59	6-8 years	2 tsp or 10 mL
60-71	9-10 years	2 1/2 tsp or 12.5 mL
72-95	11 years	3 tsp or 15 mL

* or as directed by a doctor

Other information

• Store at controlled room temperature 20° - 25°C (68° to 77°F); excursions are permitted to 15° - 30°C (59° to 86°F). [See USP Controlled Room Temperature]
• Protect from Freezing.
• Protect from Light.
  Each teaspoon (5 mL) contains: sodium 7 mg

Inactive ingredients

citric acid, FD&C Red #40, flavor, glycerin, polyethylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

Questions or comments?

Call 1-888-655-1505 (toll-free)

How Supplied

Acetaminophen Oral Solution USP, 160 mg per 5 mL is a red solution supplied as follows:

Overbagged with 5 –(160 mg -5 mL unit-dose cups) per bag, NDC: 55154-4062-5

Overbagged with 5 – (325 mg - 10.15 mL unit-dose cups) per bag, NDC: 55154-4063-5

Ovrebagged with 5 – (650 mg – 20.3 mL unit-dose cups) per bag, NDC: 55154-4064-5

Distributed By:

VistaPharm, Inc.

Largo, FL 33771, USA

VP2158R1

Distributed by:
Cardinal Health

Dublin, OH 43017

L55273460419

L55273530519

L55273610519

07/17

Principal Display Panel

Acetaminophen Oral Solution, USP

160 mg per 5 mL

•   5 Cups

Principal Display Panel

Acetaminophen Oral Solution, USP

325 mg per 10.15 mL [160 mg/5 mL]

•   5 Cups

Principal Display Panel

Acetaminophen Oral Solution, USP

650 mg per 20.3 mL [160 mg/5 mL]

5 Cups

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-4062(NDC:66689-054)
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM MONOHYDRATE (UNII: A9CO00M9HV)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-4062-5	5 in 1 BAG	05/23/2018
1		5 mL in 1 CUP, UNIT-DOSE; 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	05/23/2018

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-4063(NDC:66689-055)
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM MONOHYDRATE (UNII: A9CO00M9HV)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-4063-5	5 in 1 BAG	05/23/2018
1		10.15 mL in 1 CUP, UNIT-DOSE; 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	05/23/2018

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-4064(NDC:66689-056)
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM MONOHYDRATE (UNII: A9CO00M9HV)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-4064-5	5 in 1 BAG	05/23/2018
1		20.3 mL in 1 CUP, UNIT-DOSE; 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	05/23/2018

Labeler - Cardinal Health (603638201)