ACETAMINOPHEN

Manufacturer: Akron Pharma Inc.
Effective date: 2023-02-04
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:53:49

Label at a glance#

ProductACETAMINOPHEN

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

trmporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache

Dosage and administration

this product does not contain directions or complete warnings for adult use shake well before using mL=milliliter find the right dose on chart below, if possible, use weight to dose; otherwise use age use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not gi...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact(877) 225-6999

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

trmporarily:

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

with any other drug containing acetaminophen (prescription or non-prescription). 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 in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has

liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product: Do not exceed recommended dose

Stop use and ask a doctor if:

OTC - STOP USE SECTION

Pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
new symptoms occur.
redness or swelling is present.

These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose Warning:

OVERDOSAGE SECTION

In case of overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical
attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

this product does not contain directions or complete warnings for adult use
shake well before using
mL=milliliter
find the right dose on chart below, if possible, use weight to dose; otherwise use age
use only the enclosed dosing cup designed for use with this product.
Do not use any other dosing device.
if needed, repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
do not give more than 5 days unless directed by doctor.


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

Other information

OTHER SAFETY INFORMATION

Store at room temperature 15°-30° C (59°-86°F)
Protect from Freezing.
Protect from Light.

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

bubble gum flavor, citric acid, glycerin, polyethylene glycol 400, purified water, sodium citrate, saccharin sodium, sorbitol solution & sodium benzoate.

Questions or Comments?

Call (877) 225-6999 Monday - Friday 9AM-5PM EST

Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ - 07004

Rev 07/22

Manufactured In USA

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 OZ Package

4OZ

8 OZ Package

8OZ

16 OZ Package

16OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	5
307675	acetaminophen 32 MG/ML Oral Solution	SCD	5
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	5
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	5
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	5
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	5
307675	APAP 32 MG/ML Oral Solution	SY	5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71399-0160-4	2025-01-30	C162847	48780-1	f386c64a-0b33-0266-e053-dadaa90a7c1a	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-6	2025-01-30	C162847	48780-1	f386c64a-0b33-0266-e053-dadaa90a7c1a	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-8	2025-01-30	C162847	48780-1	f386c64a-0b33-0266-e053-dadaa90a7c1a	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-4	2023-02-10	C162847	48780-1	f386c64a-0b33-0266-e053-dadaa90a7c1a	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-8	2023-02-10	C162847	48780-1	f386c64a-0b33-0266-e053-dadaa90a7c1a	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-4	2023-01-30	C162847	48780-1	f386c64a-0b33-0266-e053-dadaa90a7c1a	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-8	2023-01-30	C162847	48780-1	f386c64a-0b33-0266-e053-dadaa90a7c1a	Acetaminophen Elxir Bubble Gum Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71399-0160-4	ACETAMINOPHEN	118 mL in 1 BOTTLE	ELIXIR	118	5
71399-0160-6	ACETAMINOPHEN	473 mL in 1 BOTTLE	ELIXIR	473	5
71399-0160-8	ACETAMINOPHEN	236 mL in 1 BOTTLE	ELIXIR	236	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71399-0160	ACETAMINOPHEN ELIXIR [AKRON PHARMA INC.]	5	Legacy NDC, 3 package rows	20230211_b31a913a-10e6-49c0-a4c9-de2c0d1ead3f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71399-0160-6	ML - Milliliter	71399-0160	0aedb9a5-cddb-4bc5-989c-533f4ac4b85a	1	2023-03-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

ACETAMINOPHEN
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
POLYETHYLENE GLYCOL 400
WATER
SODIUM CITRATE
SACCHARIN SODIUM
SORBITOL
SODIUM BENZOATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71399-0160	71399-0160-4, 71399-0160-8, 71399-0160-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
WATER	059QF0KO0R	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
db7bf2d8-02d1-467f-bce1-549ee48af7f9			b31a913a-10e6-49c0-a4c9-de2c0d1ead3f	2023-02-04	Warnings	Exact identifier spl id: db7bf2d8-02d1-467f-bce1-549ee48af7f9 spl set id: b31a913a-10e6-49c0-a4c9-de2c0d1ead3f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.