Acetaminophen by Pharmaceutical Associates, Inc. ACETAMINOPHEN solution

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Pain reliever/fever reducer

Active ingredient (in each 5 mL teaspoonful)

ACETAMINOPHEN 160 mg

Uses

temporarily relieves minor aches and pains due to:

• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps

temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• adult takes more than 6 doses in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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 you are allergic to acetaminophen or any of the inactive ingredients of this product

Ask a doctor before use if you have

• liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.

Stop use and ask a doctor if

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

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 for adults as well as children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)

age	dose
adults and children 12 years of age and over	20.3 mL (650 mg) every 4 to 6 hours; not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age	10.15 mL (325 mg) every 4 hours; not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age	7.5 mL (240 mg) every 4 hours; not to exceed 5 doses in a 24-hour period
children 2 to under 4 years of age	5 mL (160 mg) every 4 hours; not to exceed 5 doses in a 24-hour period
children under 2 years of age	consult a doctor

Other information

■ Each 5 mL contains: sodium 2 mg

■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

■ keep tightly closed  ■ protect from light

■ a red, cherry flavored solution supplied in the following oral dosage forms:

NDC: 0121-0657-05:  5 mL unit dose cup

NDC: 0121-0657-00:   Case contains 100 unit dose cups of 5 mL (0121-0657-05) packaged in 10 trays of 10 unit dose cups each.

NDC: 0121-1314-11:  10.15 mL unit dose cup

NDC: 0121-1314-00:   Case contains 100 unit dose cups of 10.15 mL (0121-1314-11) packaged in 10 trays of 10 unit dose cups each.

NDC: 0121-1971-21:  20.3 mL unit dose cup

NDC: 0121-1971-00:   Case contains 100 unit dose cups of 20.3 mL (0121-1971-21) packaged in 10 trays of 10 unit dose cups each.

Inactive ingredients:

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Questions or comments?

Call 1-800-845-8210. You may also report serious side effects to this phone number.

MANUFACTURED BY:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R07/19

PRINCIPAL DISPLAY PANEL - 5 mL Cup

Delivers 5 mL

NDC: 0121-0657-05

A CETAMINOPHEN

O RAL S OLUTION USP

160 mg/5 mL

ALCOHOL FREE

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

A06570500

PRINCIPAL DISPLAY PANEL - 10 mL Cup

Delivers 10.15 mL

NDC: 0121-1314-11

A CETAMINOPHEN

O RAL S OLUTION USP

325 mg/10.15 mL

ALCOHOL FREE

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

A06571101

PRINCIPAL DISPLAY PANEL - 20.3 mL Cup

Delivers 20.3 mL

NDC: 0121-1971-21

A CETAMINOPHEN

O RAL S OLUTION USP

650 mg/20.3 mL

ALCOHOL FREE

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

A06572101

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-0657
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

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: 0121-0657-00	10 in 1 CASE	08/01/2007
1		10 in 1 TRAY
1	NDC: 0121-0657-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 0121-0657-11	10 in 1 CASE	08/01/2007
2		10 in 1 TRAY
2		10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3	NDC: 0121-0657-21	10 in 1 CASE	08/01/2007
3		10 in 1 TRAY
3		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	08/01/2007

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-1314
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10.15 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: 0121-1314-00	10 in 1 CASE	08/01/2007
1		10 in 1 TRAY
1	NDC: 0121-1314-11	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	08/01/2007

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-1971
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20.3 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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

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: 0121-1971-00	10 in 1 CASE	08/01/2007
1		10 in 1 TRAY
1	NDC: 0121-1971-21	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	08/01/2007

Labeler - Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-0657, 0121-1314, 0121-1971)