HEADACHE RELIEF- acetaminophen, aspirin and caffeine tablet, coated 
Kroger Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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370R Headache Relief Caplets KROGER 41226 370

DRUG FACTS

ACETAMINOPHEN/ ASPIRIN (NSAID)/ CAFFEINE

Active ingredient (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Pain reliever/Pain reliever aid

Uses
temporarily relieves minor aches and pains due to:
•headache
•a cold
•arthritis
•muscular aches
•toothache
•premenstrual and menstrual cramps

Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.


Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
•hives
•facial swelling
•shock
•asthma (wheezing)

Allergyalert: 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.


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
•more than 8 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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
•are age 60 or older
•have had stomach ulcers or bleeding problems
•take a blood thinning (anticoagulant) or steroid drug
•take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
•have 3 or more alcoholic drinks every day while using this product
•take more or for a longer time than directed

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 heartbeat.

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

Ask a doctor before use if
•stomach bleeding warning applies to you
•you have a history of stomach problems, such as heartburn
•you have high blood pressure, heart disease, liver cirrhosis or kidney disease
•you are taking a diuretic

Ask a doctor or pharmacist before use if you are
•taking a prescription drug for diabetes, gout, or arthritis
•taking any other drug or are under a doctor’s care for any serious condition

Stop using and ask a doctor if
•symptoms do not improve
•new symptoms occur
•pain or fever persists or gets worse
•you experience any of the following signs of stomach bleeding:
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
•ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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.

Directions:
•do not use more than directed
•drink a full glass of water with each dose
•adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
•children under 12 years: ask a doctor

OTHER INFORMATION

Other information

Inactive ingredients
carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

call 1-800-632-6900

headache-100ct-labelHeadache Relief 24 ct- Carton labelHeadache Relief 24 ct- Bottle labelHeadache Relief 100 ct- Carton label

HEADACHE RELIEF 
acetaminophen, aspirin and caffeine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-370
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE ((Capsule Shaped Tablet)) Size18mm
FlavorImprint Code TCL;370
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-370-421 in 1 CARTON04/10/2021
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41226-370-011 in 1 CARTON04/10/2021
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/10/2021
Labeler - Kroger Company (006999528)
Registrant - Time Cap Laboratories, Inc. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Laboratories, Inc.037052099manufacture(41226-370)

Revised: 4/2021
Document Id: bf36c5e9-62b3-1b2d-e053-2a95a90a337c
Set id: bbed29a1-3c52-3531-e053-2995a90a686c
Version: 2
Effective Time: 20210405
 
Kroger Company