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NDC 00363-0428-12 Tension Headache Relief 500; 65 mg/1; mg/1 Details

Tension Headache Relief 500; 65 mg/1; mg/1

Tension Headache Relief is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is ACETAMINOPHEN; CAFFEINE.

Product Information

NDC	00363-0428
Product ID	0363-0428_e3b2b757-6c17-43c3-ae3d-91d7f0337298
Associated GPIs	62100010002810
GCN Sequence Number	004930
GCN Sequence Number Description	nicotine polacrilex GUM 2 MG BUCCAL
HIC3	J3A
HIC3 Description	SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS)
GCN	03200
HICL Sequence Number	002049
HICL Sequence Number Description	NICOTINE POLACRILEX
Brand/Generic	Generic
Proprietary Name	Tension Headache Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Caffeine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	500; 65
Active Ingredient Units	mg/1; mg/1
Substance Name	ACETAMINOPHEN; CAFFEINE
Labeler Name	Walgreen Company
Pharmaceutical Class	Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	n/a

Package

Package Images

NDC 00363-0428-12 (00363042812)

Pricing Information	N/A
NDC Package Code	0363-0428-12
Billing NDC	00363042812
Package	1 BOTTLE, PLASTIC in 1 CARTON (0363-0428-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date	2007-01-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 804b850c-962d-4d83-88d0-e0c21537e5f4 Details

Active ingredients (in each caplet)

Acetaminophen 500 mg

(formulated with 65 mg caffeine)

Purpose

Pain reliever

Uses

temporarily relieves minor aches and pains due to:
- headache
- muscular aches

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:

blisters
rash
skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

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

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

new symptoms occur
painful area is red or swollen
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed
adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets in 24 hours.
children under 12 years: ask a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to Excedrin® Tension

Headache Caplets active ingredients††

NDC 0363-0428-12

Tension Headache Relief

ACETAMINOPHEN / CAFFEINE / PAIN RELIEVER

ASPIRIN FREE

CAPLETS

100 CAPLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or distributed by

GSK group of companies, owner of the registered

trademark Excedrin® Tension Headache Caplets.

50844 REV1119A42812

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens 100% SATISFACTION GUARANTEED

Walgreens.com ©2018 Walgreen Co.

44-428

INGREDIENTS AND APPEARANCE

TENSION HEADACHE RELIEF

acetaminophen, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0428
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
TALC (UNII: 7SEV7J4R1U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CROSPOVIDONE (UNII: 2S7830E561)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;428
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0428-12	1 in 1 CARTON	01/17/2007	05/18/2023
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:0363-0428-08	1 in 1 CARTON	01/17/2007	07/15/2018
2		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:0363-0428-57	1 in 1 CARTON	01/17/2007	02/07/2021
3		125 in 1 BOTTLE, PLASTIC; 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	01/17/2007	05/18/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0363-0428)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0428)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(0363-0428)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0363-0428)

Revised: 11/2021

Document Id: e3b2b757-6c17-43c3-ae3d-91d7f0337298

Set id: 804b850c-962d-4d83-88d0-e0c21537e5f4

Version: 11

Effective Time: 20211116