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NDC 60687-0571-37 Acetaminophen 160 mg/5mL Details

Acetaminophen 160 mg/5mL

Acetaminophen is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by American Health Packaging. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 60687-0571-37
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	60687-0571
Product ID	60687-571_e0df8d5a-b84f-c0c5-e053-2995a90a70ec
Associated GPIs	64200010002010
GCN Sequence Number	065758
GCN Sequence Number Description	acetaminophen SOLUTION 650MG/20.3 ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	27802
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	160
Active Ingredient Units	mg/5mL
Substance Name	ACETAMINOPHEN
Labeler Name	American Health Packaging
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	n/a

Package

Package Images

NDC 60687-0571-37 (60687057137)

Pricing Information	N/A
NDC Package Code	60687-571-37
Billing NDC	60687057137
Package	10 TRAY in 1 CASE (60687-571-37) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-571-53) / 20.3 mL in 1 CUP, UNIT-DOSE (60687-571-24)
Marketing Start Date	2021-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7212eddc-7483-4df5-8255-6b502db37757 Details

Active ingredient

(in each 10.15 mL cup) Acetaminophen, USP 325 mg

(in each 20.30 mL cup) Acetaminophen, USP 650 mg

Purpose

Pain reliever/fever reducer

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 (10.15 mL unit dose cups)

Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 unit dose cups (3,250 mg) in 24 hours for adults or 5 unit dose cups (1,625 mg) in 24 hours for children, which is the maximum daily amount for this product. Severe liver damage may occur if

adult takes more than 10 unit dose cups (101.50 mL) in 24 hours
child takes more than 5 unit dose cups (50.75 mL) in 24 hours, which is the maximum daily amount
taken with other drugs containing acetaminophen
adult has 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.

Warnings (20.30 mL unit dose cups)

Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 5 unit dose cups (3,250 mg) in 24 hours for adults, which is the maximum daily amount for this product. Severe liver damage may occur if

adult takes more than 5 unit dose cups (101.50 mL) in 24 hours
taken with other drugs containing acetaminophen
adult has 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.

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

Ask a doctor

before use if the user has liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or last for more than 10 days in adults
pain gets worse or last for more than 5 days in children under 12 years
fever gets worse or lasts for more than 3 days
new symptoms occur
redness or swelling is present

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: 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 for children even if you do not notice any signs or symptoms.

Directions (10.15 mL unit dose cups)

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 unit dose cups (20.30 mL) every 4 to 6 hours while symptoms last do not take more than 10 unit dose cups (101.50 mL0 in 24 hours, unless directed by a doctor do not use for mor than 10 days unless directed by a doctor
children 6 years to under 12 years	take 1 unit dose cup (10.15 mL) every 4 to 6 hours while symptoms last do not take more than 5 unit does cups (50.75 mL) in 24 hours do not use for more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

Directions (20.30 mL unit dose cups)

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 1 unit dose cups (20.30 mL) every 4 to 6 hours while symptoms last do not take more than 5 unit dose cups (101.50 mL0 in 24 hours, unless directed by a doctor do not use for mor than 10 days unless directed by a doctor
children 6 years to under 12 years	ask a doctor

Other Information

each 10.15 mL contains: sodium 33.5 mg
each 22.30 mL contains: sodium 67 mg
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
Protect from light
DO NOT USE IF SEAL IS BROKEN
This drug product is supplied in 10.15 mL unit dose cups as:100 cups (10 x 10) NDC 60687-571-56
This drug product is supplied in 20.30 mL unit dose cups as:100 cups (10 x 10) NDC 60687-571-37

Inactive Ingredients

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, artificial cherry flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin

Packaging Information

American Health Packaging unit dose cups (see Other Information section) contain drug product from Woodfield Pharmaceutical LLC as follows:

(325 mg per 10.15 mL / 100UD) NDC 60687-571-56 packaged from NDC 72207-114

(650 mg per 20.30 mL / 100UD) NDC 60687-571-37 packaged from NDC 72207-114

Distributed by:

American Health Packaging

Columbus, Ohio 43217

8457156/0621F

8457137/0621F

Package/Label Principal Display Panel - Tray

Acetaminophen

Oral Solution, USP

Pain Reliever/Fever Reducer

325 mg/10.15 mL

Artificial Cherry Flavor

FOR INSTITUTIONAL USE ONLY

Store at 20°C to 25°C (68°F to 77°F),

excursions permitted between

15°C and 30°C (between 59°F and 86°F).

Protect from light.

8457156/0621F

Acetaminophen

Oral Solution, USP

Pain Reliever/Fever Reducer

650 mg/20.30 mL

Artificial Cherry Flavor

FOR INSTITUTIONAL USE ONLY

Store at 20°C to 25°C (68°F to 77°F),

excursions permitted between

15°C and 30°C (between 59°F and 86°F).

Protect from light.

8457137/0621F

Package/Label Principal Display Panel – Cup – 325 mg per 10.15 mL

NDC 60687- 571-42

Acetaminophen

Oral Solution, USP

Pain Reliever/Fever Reducer

325 mg/10.15 mL

Delivers 10.15 mL

Protect from light.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

0457156/0620

Package/Label Principal Display Panel – Cup – 650 mg per 20.30 mL

NDC 60687- 571-24

Acetaminophen

Oral Solution, USP

Pain Reliever/Fever Reducer

650 mg/20.30 mL

Delivers 20.30 mL

Protect from light.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

0457137/0620

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60687-571
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60687-571-56	10 in 1 CASE	07/01/2021	09/30/2023
1	NDC:60687-571-48	10 in 1 TRAY
1	NDC:60687-571-42	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC:60687-571-37	10 in 1 CASE	07/01/2021	09/30/2023
2	NDC:60687-571-53	10 in 1 TRAY
2	NDC:60687-571-24	20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	07/01/2021	09/30/2023

Labeler - American Health Packaging (929561009)

Revised: 6/2022

Document Id: e0df8d5a-b84f-c0c5-e053-2995a90a70ec

Set id: 7212eddc-7483-4df5-8255-6b502db37757

Version: 3

Effective Time: 20220607

Search by Drug Name or NDC

NDC 60687-0571-37 Acetaminophen 160 mg/5mL Details

Acetaminophen 160 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 60687-0571-37 (60687057137)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7212eddc-7483-4df5-8255-6b502db37757 Details

Active ingredient

Purpose

Uses

Warnings (10.15 mL unit dose cups)

Warnings (20.30 mL unit dose cups)

Do not use

Ask a doctor

Ask a doctor or pharmacist before use if the user is

Stop use and ask a doctor if

If pregnant or breast-feeding

Keep Out of Reach of Children

Directions (10.15 mL unit dose cups)

Directions (20.30 mL unit dose cups)

Other Information

Inactive Ingredients

Packaging Information

Package/Label Principal Display Panel - Tray

Package/Label Principal Display Panel – Cup – 325 mg per 10.15 mL

Package/Label Principal Display Panel – Cup – 650 mg per 20.30 mL

INGREDIENTS AND APPEARANCE

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