EXTRA PAIN RELIEF- acetaminophen, aspirin and caffeine tablet, film coated 
TIME CAP LABS

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Acetaminophen 250 mg, Aspirin 250 mg (NSAID), and Caffeine 65 mg Tablets

DRUG FACTS

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

Purpose
Pain reliever
Pain reliever aid

Uses

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

Ask a doctor before use if
• you have liver disease
• 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
• you have asthma

Ask a doctor or pharmacist before use if you are taking

Stop use and ask a doctor if
• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
o feel faint
o vomit blood
o have bloody or black stools
o have stomach pain that does not get better
• ringing in the ears or loss of hearing occurs
• 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
• any new symptoms occur
These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 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.

DIRECTIOINS

Directions

OTHER INFORMATION

Other information

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

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

timely-300s-label-headache-relief370R-Timely-200s-label24ct carton

24ct label

100ct carton

100ct label

EXTRA PAIN RELIEF 
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-370
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE ((CAPSULE SHAPED TABLET)) Size18mm
FlavorImprint Code TCL370
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-370-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/16/2021
2NDC:49483-370-20200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2013
3NDC:49483-370-0020000 in 1 CARTON; Type 0: Not a Combination Product02/22/2016
4NDC:49483-370-421 in 1 CARTON07/16/2021
424 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:49483-370-31300 in 1 BOTTLE; Type 0: Not a Combination Product03/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01311/01/2013
Labeler - TIME CAP LABS (037052099)
Registrant - TIME CAP LABS (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABS037052099manufacture(49483-370)

Revised: 3/2024
Document Id: 13ad4f0e-3340-b421-e063-6294a90a7696
Set id: 59482917-f80b-4bed-9218-068b35366eb3
Version: 7
Effective Time: 20240315
 
TIME CAP LABS