8 HR PAIN RELIEF- acetaminophen tablet, extended release 
DOLGENCORP, INC.

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704R 55910-895 Dollar General Acetaminophen Extended-Release Tablets 650 mg - Muscle Aches & Pain

Drug Facts

Active ingredient (in each caplet)
Acetaminophen 650 mg

Purpose
Pain reliever/fever reducer

Uses
• temporarily relieves minor aches and pains due to:
o muscular aches
o backache
o minor pain of arthritis
o toothache
o premenstrual and menstrual cramps
o headache
o the common cold
• temporarily reduces fever

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.

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

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 symptoms 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.

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.

Directions
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

Other information
• store at 20-25ºC (68-77ºF)
• The FDA approved Dissolution methods differ from USP

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

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

704R-DG-APAP-50s-Label704R-DG-APAP-50s-ifc

8 HR PAIN RELIEF 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-895
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
TRIACETIN (UNII: XHX3C3X673)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (White to off White) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 71
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-895-051 in 1 BOTTLE04/29/2023
150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21548604/29/2023
Labeler - DOLGENCORP, INC. (068331990)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Ltd925822975manufacture(55910-895)

Revised: 4/2023
Document Id: f9c35f34-c494-2573-e053-6294a90aee3a
Set id: ea2ebb7b-ceab-567a-e053-2995a90aa402
Version: 2
Effective Time: 20230420
 
DOLGENCORP, INC.