RxNorm Names
Review RxNorm Normal Forms
EXTRA STRENGTH ASPIRIN FREE PAIN RELIEF
(acetaminophen)
capsule
[Safeway]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fde76ae0-0362-40e4-ac83-d6c6b9264861| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph not final |
Uses
- temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pains of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warnings: 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
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.
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.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 4 to 6 hours while symptoms last
- swallow whole - do not crush, chew or dissolve
- do not take more than 8 caplets in 24 hours
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: doi not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
Other information
- store at 25ºC (77ºC); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, flavor, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide
*may contain this ingredient
Principal display panel
NDC 21130-445-15
Compare to Tylenol® Extra Strength Cool Caplets active ingredient†
Extra Strength
Aspirin Free Pain Relief
Acetaminophen, 500 mg
• Cool Caplets
• Pain Reliever
• Fever Reducer
50 CAPLETS, 500 mg EACH
SAFEWAY™
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Tylenol® Extra Strength Cool Caplets.
50844 REV0112A44515
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Safeway 44-445
| EXTRA STRENGTH ASPIRIN FREE PAIN RELIEF
acetaminophen capsule |
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| Labeler - Safeway (009137209) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 038154464 | PACK(21130-445) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 832867894 | MANUFACTURE(21130-445) | |
