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NDC 00363-0669-01 Extra Strength Pain Reliever 500 mg/1 Details

Extra Strength Pain Reliever 500 mg/1

Extra Strength Pain Reliever is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREENS. 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: 00363-0669-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	00363-0669
Product ID	0363-0669_d24f2856-6117-3ac5-e053-2a95a90a1a2c
Associated GPIs
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	Extra Strength Pain Reliever
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen tablets 500 mg
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	WALGREENS
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0669-01 (00363066901)

Pricing Information	N/A
NDC Package Code	0363-0669-01
Billing NDC	00363066901
Package	1 BOTTLE in 1 CARTON (0363-0669-01) / 100 TABLET in 1 BOTTLE
Marketing Start Date	2021-10-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c25bfe92-0196-0489-e053-2995a90abea1 Details

DRUG FACTS

SPL UNCLASSIFIED SECTION

Active ingredient

(in each tablet)

Acetaminophen 500 mg

SPL UNCLASSIFIED SECTION

Purpose

Pain reliever/fever reducer

SPL UNCLASSIFIED SECTION

Uses

temporarily relieves minor aches and pains due to:

headache
the common cold
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 4,000 mg of acetaminophen 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.

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

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have liver disease

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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

pain gets worse or lasts more than 10 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 (see overdose warning)

adults and children 12 years and over:

take 2 tablets every 6 hours while symptoms last
do not take more than 6 tablets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

OTHER INFORMATION

Other information

store between 20-25°C (68-77°F)

SPL UNCLASSIFIED SECTION

Inactive ingredients carnauba wax, FD&C Red #40 aluminum lake, hypromellose, polyethylene glycol, povidone, pregelatinized

starch, sodium starch glycolate*, stearic acid, sucralose, titanium dioxide *may contain this ingredient

SPL UNCLASSIFIED SECTION

Questions and comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEVER

acetaminophen tablets 500 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0669
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	TCL342
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0669-01	1 in 1 CARTON	10/13/2021
1		100 in 1 BOTTLE; 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	10/13/2021

Labeler - WALGREENS (008965063)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
TIME CAP LABORATORIES, INC.		037052099	manufacture(0363-0669)

Revised: 12/2021

Document Id: d24f2856-6117-3ac5-e053-2a95a90a1a2c

Set id: c25bfe92-0196-0489-e053-2995a90abea1

Version: 3

Effective Time: 20211214

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NDC 00363-0669-01 Extra Strength Pain Reliever 500 mg/1 Details

Extra Strength Pain Reliever 500 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00363-0669-01 (00363066901)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c25bfe92-0196-0489-e053-2995a90abea1 Details

DRUG FACTS

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OTHER INFORMATION

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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