Label: QAULITY CHOICE PAIN RELIEF EXTRA STRENGTH- acetaminophen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-564-08 - Packager: CHAIN DRUG MARKETING ASSOCIATION INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 23, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Sever liver damage may occur if you take
- more than 8 tablespoonfuls (4,000 mg of acetaminophen) in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyd ay while using this product
Allergy alert: acetaminophen may cause sever skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- If a skin reaction occurs, stop use and seek mdical 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 thris product.
Ask a doctor before use if you have liver disease
Ask a doctor before use if you are taking the blodd thinning drug warfarin.
When using this product: Do not exceed recomended dose.
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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QAULITY CHOICE PAIN RELIEF EXTRA STRENGTH
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-564 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-564-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/01/2020 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
