REGULAR STRENGTH QPAP - acetaminophen tablet 
Bryant Ranch Prepack

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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REGULAR STRENGTH QPAP - Acetaminophen Tablets

Drug Facts

Active Ingredient

(in each tablet)

Acetaminophen 325 mg

Purposes

Pain Reliever/Fever Reducer

Uses

Temporarily reduces fever and relieves minor aches and pains caused by:

  • Common cold
  • headache
  • toothache
  • muscular aches
  • Premenstrual and menstrual cramps

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 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.
  • 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
  • Redness or swelling is present
  • New symptoms appear

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:

Taking more than the recommended dose (overdose) may cause liver damage. In the 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 overtake 2 tablets every 4 to 6 hours while symptoms last, not more than 12 tablets in 24 hours
    children 6 years to 11 yearstake 1 tablet every 4 to 6 hours while symptoms last, not more than 5 tablets in 24 hours
    children under 6 yearsdo not use adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

    Other Information

  • store at room temperature 15° to 30°C (59° to 86°F)
  • you may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811

Inactive Ingredients

polyvinylpyrrolidone, pregelatinized corn starch, sodium  carboxymethylcellulose/sodium starch glycolate, stearic acid

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS DAMAGED OR MISSING

Made in the USA

For Qualitest Pharmaceuticals

Huntsville, AL 35811

HOW SUPPLIED

Product: 63629-1518

NDC: 63629-1518-7 60 TABLET in a BOTTLE

NDC: 63629-1518-4 2 TABLET in a BOTTLE

NDC: 63629-1518-5 6 TABLET in a BOTTLE

NDC: 63629-1518-6 10 TABLET in a BOTTLE

NDC: 63629-1518-1 20 TABLET in a BOTTLE

NDC: 63629-1518-3 30 TABLET in a BOTTLE

NDC: 63629-1518-2 100 TABLET in a BOTTLE

NDC: 63629-1518-8 90 TABLET in a BOTTLE

NDC: 63629-1518-9 40 TABLET in a BOTTLE

NDC: 63629-1518-0 24 TABLET in a BOTTLE

Acetaminophen 325 mg. Tablet

Label Image
REGULAR STRENGTH QPAP 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-1518(NDC:0603-0263)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUND (Flat Face Bevel Edge) Size10mm
FlavorImprint Code 0027;V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-1518-760 in 1 BOTTLE; Type 0: Not a Combination Product06/02/201104/04/2018
2NDC:63629-1518-42 in 1 BOTTLE; Type 0: Not a Combination Product06/02/201104/04/2018
3NDC:63629-1518-56 in 1 BOTTLE; Type 0: Not a Combination Product06/02/201104/04/2018
4NDC:63629-1518-610 in 1 BOTTLE; Type 0: Not a Combination Product06/02/201104/04/2018
5NDC:63629-1518-120 in 1 BOTTLE; Type 0: Not a Combination Product06/02/201104/04/2018
6NDC:63629-1518-330 in 1 BOTTLE; Type 0: Not a Combination Product06/02/201104/04/2018
7NDC:63629-1518-2100 in 1 BOTTLE; Type 0: Not a Combination Product06/02/201104/04/2018
8NDC:63629-1518-890 in 1 BOTTLE; Type 0: Not a Combination Product06/02/201104/04/2018
9NDC:63629-1518-940 in 1 BOTTLE; Type 0: Not a Combination Product06/02/201104/04/2018
10NDC:63629-1518-024 in 1 BOTTLE; Type 0: Not a Combination Product06/02/201104/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/02/201104/04/2018
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-1518) , RELABEL(63629-1518)

Revised: 5/2021
Document Id: 35e2f79c-5337-43f3-b67c-945297781315
Set id: 42e4219a-a4ef-f090-f6a4-2fd2e213d397
Version: 15
Effective Time: 20210530
 
Bryant Ranch Prepack