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NDC 49483-0699-05 Acetaminophen 650 mg/1 Details

Acetaminophen 650 mg/1

Acetaminophen is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, 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: 49483-0699-05
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	49483-0699
Product ID	49483-699_eb0bcd1a-2f6b-5e5e-e053-2995a90ab995
Associated GPIs	64200010000420
GCN Sequence Number	022123
GCN Sequence Number Description	acetaminophen TABLET ER 650 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16910
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen tablet extended release
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	650
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	TIME CAP LABORATORIES, INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA215486
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49483-0699-05 (49483069905)

Pricing Information	N/A
NDC Package Code	49483-699-05
Billing NDC	49483069905
Package	50 BOTTLE in 1 CARTON (49483-699-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date	2021-10-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cd4d0ad4-7206-94c8-e053-2a95a90aaa14 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each caplet)

Acetaminophen 650 mg

SPL UNCLASSIFIED SECTION

Purpose

Pain reliever/fever reducer

SPL UNCLASSIFIED SECTION

Uses

For Arthritis Pain

temporarily relieves minor aches and pains due to:

minor pain of arthritis
muscular aches
backache
premenstrual and menstrual cramps
the common cold
headache
toothache

temporarily reduces fever

For Muscle Aches & Pains

temporarily relieves minor aches and pains due to:

muscular aches
backache
minor pain of arthritis
toothache
premenstrual and menstrual cramps
headache
the common cold

temporarily reduces fever

SPL UNCLASSIFIED SECTION

Warnings

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

more than 6 caplets 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.

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

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 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.

SPL UNCLASSIFIED SECTION

Directions

For Arthritis Pain

Do not take more than directed. See overdose warning

adults:

take 2 caplets every 8 hours with water
swallow whole; do not crush, chew, split or dissolve
do not take more than 6 caplets in 24 hours
do not use for more than 10 days unless directed by a doctor

under 18 years of age: ask a doctor

For Muscle Aches & Pains

Do not take more than directed. See overdose warning

adults and children 12 years and over:

take 2 caplets every 8 hours with water
swallow whole; do not crush, chew, split or dissolve
do not take more than 6 caplets in 24 hours
do not use for more than 10 days unless directed by a doctor

children under 12 years: do not use

SPL UNCLASSIFIED SECTION

Other information

store between 20-25°C (68-77°F)
The FDA approved Dissolution methods differ from USP

SPL UNCLASSIFIED SECTION

Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet extended release tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49483-699
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TRIACETIN (UNII: XHX3C3X673)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)

Product Characteristics
Color	white (White to off white)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	71
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49483-699-40	400 in 1 BOTTLE; Type 0: Not a Combination Product	10/04/2021
2	NDC:49483-699-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/04/2021
3	NDC:49483-699-05	50 in 1 CARTON	10/04/2021
3		1 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:49483-699-26	225 in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2022
5	NDC:49483-699-42	1 in 1 CARTON	11/07/2022
5		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215486	10/04/2021

MUSCLE ACHES AND PAINS ACETAMINOPHEN EXTENDED RELEASE

acetaminophen tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49483-704
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TRIACETIN (UNII: XHX3C3X673)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (White to off white)	Score	no score
Shape	CAPSULE (Capsule-shaped tablet)	Size	19mm
Flavor		Imprint Code	71
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49483-704-05	1 in 1 CARTON	11/07/2022
1		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215486	11/07/2022

Labeler - TIME CAP LABORATORIES, INC. (037052099)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
MARKSANS PHARMA LIMITED		925822975	manufacture(49483-699, 49483-704)

Revised: 10/2022

Document Id: eb0bcd1a-2f6b-5e5e-e053-2995a90ab995

Set id: cd4d0ad4-7206-94c8-e053-2a95a90aaa14

Version: 2

Effective Time: 20221028

Search by Drug Name or NDC

NDC 49483-0699-05 Acetaminophen 650 mg/1 Details

Acetaminophen 650 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49483-0699-05 (49483069905)

Contents

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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