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NDC 70518-1101-01 ACETAMINOPHEN 325 mg/1 Details

ACETAMINOPHEN 325 mg/1

ACETAMINOPHEN is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK INC.. 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: 70518-1101-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	70518-1101
Product ID	70518-1101_e89441e9-44ea-6912-e053-2995a90a4703
Associated GPIs	64200010000310
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ACETAMINOPHEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	ACETAMINOPHEN
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	325
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	REMEDYREPACK INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-1101-01 (70518110101)

Pricing Information	N/A
NDC Package Code	70518-1101-1
Billing NDC	70518110101
Package	30 TABLET in 1 BLISTER PACK (70518-1101-1)
Marketing Start Date	2021-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 14f8f881-da8e-4c33-a1df-fd2c4d738aec Details

DRUG FACTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Acetaminophen 325 mg

SPL UNCLASSIFIED SECTION

Purpose

Pain reliever/fever reducer

SPL UNCLASSIFIED SECTION

Uses

temporarily relieves minor aches and pains due to:

the common cold

headache

backache

minor pain of arthritis

toothache

muscular aches

premenstrual and menstrual cramps

temporarily reduces fever

SPL UNCLASSIFIED SECTION

Warnings

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

more than 12 tablets in 24 hours which is the maximum daily amount
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.

SPL UNCLASSIFIED SECTION

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
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have liver disease

SPL UNCLASSIFIED SECTION

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

SPL UNCLASSIFIED SECTION

Stop using and ask a doctor if

symptoms do not improve
new symptoms occur
pain or fever persist or get worse

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center

(1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

SPL UNCLASSIFIED SECTION

Directions

do not take more than directed

adults and children 12 years and over

take 2 tablets (650 mg) every 4 to 6 hours while symptoms last
do not take more than 10 tablets (3,250 mg) in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

children 6 years to under 12 years

take 1 tablet (325 mg) every 4 to 6 hours while symptoms last
do not take more than 5 tablets (1,625 mg) 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

Other information

SODIUM FREE
store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

SPL UNCLASSIFIED SECTION

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain this ingredient

PRINCIPAL DISPLAY PANEL

DRUG: ACETAMINOPHEN

GENERIC: ACETAMINOPHEN

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1101-0

NDC: 70518-1101-1

NDC: 70518-1101-2

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: TCL340

PACKAGING: .30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 20 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

ACETAMINOPHEN 325mg in 1

INACTIVE INGREDIENT(S):

POVIDONE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-1101(NDC:49483-340)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL340
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-1101-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/06/2018
2	NDC:70518-1101-1	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	07/15/2021
3	NDC:70518-1101-2	20 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/12/2021	10/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	04/06/2018

Labeler - REMEDYREPACK INC. (829572556)

Revised: 9/2022

Document Id: e89441e9-44ea-6912-e053-2995a90a4703

Set id: 14f8f881-da8e-4c33-a1df-fd2c4d738aec

Version: 9

Effective Time: 20220913

Search by Drug Name or NDC

NDC 70518-1101-01 ACETAMINOPHEN 325 mg/1 Details

ACETAMINOPHEN 325 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70518-1101-01 (70518110101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 14f8f881-da8e-4c33-a1df-fd2c4d738aec Details

DRUG FACTS

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OTHER INFORMATION

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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