Qaulity Choice Pain Relief Extra Strength
- Manufacturer
- CHAIN DRUG MARKETING ASSOCIATION INC
- Effective date
- 2020-12-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:35:44
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
Pain Reliever/Fever Reducer
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains
- temporarily reduces fever
WARNINGS SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get midcal help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions Do not take more than directed
| Age | Dose |
| Adults and children12 years of age and older | Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed. not more than 6 tablespoonfuls in 24 hours |
| Children under 12 years | Do not use |
INACTIVE INGREDIENT SECTION
Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, porpylparaben, purified water, sodium citrate, sucralose.
OTC - QUESTIONS SECTION
Question or comments? 1-800-540-3765
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307684 | acetaminophen 500 MG in 15 mL Oral Solution | PSN | 1 |
| 307684 | acetaminophen 33.3 MG/ML Oral Solution | SCD | 1 |
| 307684 | APAP 1000 MG per 30 ML Oral Solution | SY | 1 |
| 307684 | APAP 167 MG per 5 ML Oral Solution | SY | 1 |
| 307684 | APAP 33.3 MG/ML Oral Solution | SY | 1 |
| 307684 | APAP 500 MG per 15 ML Oral Solution | SY | 1 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63868-564-08 | 2022-01-28 | C162847 | 48780-1 | d6a99b3a-0066-a426-e053-dadaa90af4c2 | 5017f066-5642-44df-b57b-a827e7dd4f20 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-564-08 | Qaulity Choice Pain Relief Extra Strength | 237 mL in 1 BOTTLE | LIQUID | 237 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Qaulity Choice Pain Relief Extra Strength
- Acetaminophen
- ANHYDROUS CITRIC ACID
- FD&C RED NO. 40
- METHYLPARABEN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63868-564 | 63868-564-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| c0c8e3f6-2940-4c0e-9c63-350dc0be5c53 | 5017f066-5642-44df-b57b-a827e7dd4f20 | 2020-12-23 | Warnings | c0c8e3f6-2940-4c0e-9c63-350dc0be5c53 5017f066-5642-44df-b57b-a827e7dd4f20 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
