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NDC 60760-0491-50 HEALTH SENSE TACTINAL Regular Strength 325 mg/1 Details

HEALTH SENSE TACTINAL Regular Strength 325 mg/1

HEALTH SENSE TACTINAL Regular Strength is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by St. Mary's Medical Park Pharmacy. 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: 60760-0491-50
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	60760-0491
Product ID	60760-491_7b339a74-8a38-23ee-e053-2991aa0a278b
Associated GPIs	64200010000310
GCN Sequence Number	004489
GCN Sequence Number Description	acetaminophen TABLET 325 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16964
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	HEALTH SENSE TACTINAL Regular Strength
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	St. Mary's Medical Park Pharmacy
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2022-12-31

Package

Package Images

NDC 60760-0491-50 (60760049150)

Pricing Information	N/A
NDC Package Code	60760-491-50
Billing NDC	60760049150
Package	50 TABLET in 1 BOTTLE, PLASTIC (60760-491-50)
Marketing Start Date	2018-11-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7bd0b31d-7a58-e273-e053-2a91aa0ae100 Details

Active Ingredients

Acetaminophen 325 mg

Purpose

Pain Reliever/Fever Reducer

Uses

temporarily relieves minor aches and pains
temporarily reduces fever

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

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.

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptom occur
redness or swelling is present

These could be signs of a serious condition.

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

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children.

Directions

do not take more than directed

Adults and children 12 years of age and over	Take 2 tablets every 4-6 hours, as needed. Do not take more than 12 tablets in 24 hours.
Children under 12 years	Ask a doctor

Other information

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
store at 20⁰C-25⁰C (68⁰F-77⁰F)
for institutional use only

Inactive ingredients

povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and probylparaben

package label

INGREDIENTS AND APPEARANCE

HEALTH SENSE TACTINAL REGULAR STRENGTH

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60760-491(NDC:62107-052)
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)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 68401960MK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND (Round)	Size	10mm
Flavor		Imprint Code	GC101
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60760-491-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/20/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	11/20/2018

Labeler - St. Mary's Medical Park Pharmacy (063050751)

Name	Address	ID/FEI	Business Operations
Establishment
St. Mary's Medical Park Pharmacy		063050751	relabel(60760-491) , repack(60760-491)

Name	Address	ID/FEI	Business Operations
Establishment
Geri-Care Pharmaceutical Corp		611196254	repack(60760-491)

Revised: 11/2018

Document Id: 7b339a74-8a38-23ee-e053-2991aa0a278b

Set id: 7bd0b31d-7a58-e273-e053-2a91aa0ae100

Version: 1

Effective Time: 20181121