ACETAMINOPHEN (RED) - One2zee Limited Liability Company | Medgel Private Limited

Manufacturer: One2zee Limited Liability Company | Medgel Private Limited
Effective date: 2019-02-22
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:02:09

Label at a glance#

ProductACETAMINOPHEN (RED)

Active ingredientACETAMINOPHEN

Label structure15 sections

Indications and 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

Dosage and administration

Do not take more than directed ( see Overdose warning ) adults and children 12 years and over take 2 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels in 24 hours do not use for more than 5 days unless d...

Storage and handling

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses 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

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children under 12 years
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 - PREGNANCY OR BREAST FEEDING SECTION

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

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 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

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed
(seeOverdose warning)


adults and children 12 years and over	take 2 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor
children 6-11 years	take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels in 24 hours do not use for more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

Other Information

STORAGE AND HANDLING SECTION

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, gelatin, sorbitol, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, titanium dioxide, purified water

PRINCIPAL DISPLAY PANEL - Shipping Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACETAMINOPHEN CAPSULES, 325 mg

Quantity : 48 Bags of 300 Capsules each
NDC. No : 55629-718-01

Important:

1. Inspect immediately upon receipt

2. This is bulk shipment intended for further processing only
3. Store at controlled temperature of 59°F to 86°F (15°C to 30°C) avoid high humidity and excessive heat above 104°F (40°C)

PRINCIPAL DISPLAY PANEL - Shipping Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198436	acetaminophen 325 MG Oral Capsule	PSN	1
198436	acetaminophen 325 MG Oral Capsule	SCD	1
198436	APAP 325 MG Oral Capsule	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55629-718-01	2021-01-29	C162847	48780-1	ba0f9c33-39a2-a910-e053-dadaa90a0b85	ACETAMINOPHEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55629-718-01	ACETAMINOPHEN (RED)	48 in 1 BOX	CAPSULE, LIQUID FILLED	48		1
55629-718-02	ACETAMINOPHEN (RED)	300 in 1 BAG	CAPSULE, LIQUID FILLED	300		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55629-718	ACETAMINOPHEN (RED) (ACETAMINOPHEN (RED) - ACETAMINOPHEN CAPSULE LIQUID FILLED) CAPSULE, LIQUID FILLED [ONE2ZEE LIMITED LIABILITY COMPANY]	1	Legacy NDC, 2 package rows	20190225_b2c38aaa-c383-49f8-8151-fa0bf5d10ba3.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

ACETAMINOPHEN (RED)
ACETAMINOPHEN (RED) - Acetaminophen capsule liquid filled
ACETAMINOPHEN
PROPYLENE GLYCOL
POVIDONE K30
FD&C RED NO. 40
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
GELATIN
GLYCERIN
SORBITOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55629-718	55629-718-02, 55629-718-01

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
ACETAMINOPHEN	362O9ITL9D	ACTIB
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POVIDONE K30	U725QWY32X	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT

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
47e1af5e-e6b7-4543-829d-ca1605319872			b2c38aaa-c383-49f8-8151-fa0bf5d10ba3	2019-02-22	Warnings	Exact identifier spl id: 47e1af5e-e6b7-4543-829d-ca1605319872 spl set id: b2c38aaa-c383-49f8-8151-fa0bf5d10ba3

Reported adverse events (FAERS/openFDA)#

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