Label: SOUND BODY EXTRA STRENGTH PAIN RELIEVER- acetaminophen 500 mg tablet
- NDC Code(s): 69168-913-01
- Packager: Allegiant Health
- 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.
Updated November 15, 2017
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- Active ingredient (in each caplet)
Pain reliever/fever reducerClose
temporarily relieves minor aches and pains due to:
- the common cold
- minor pain of arthritis
- muscular aches
- premenstrual and menstrual cramps temporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000mg of acetaminophen in 24 hours
- 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
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
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
- You may report side effects to 1-888-952-0050
Keep out of reach of children.
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see overdose warning)
Adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last
- do not take more than 8 caplets in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
Children under 12 years of age: ask a doctorClose
- Other information
- store between 20º-25ºC (68º-77ºF)
- do not use if imprinted safety seal under cap is broken or missing
- Inactive ingredients
corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to the Active Ingredient in Tylenol® Caplets*
See New Warnings Information
Pain Reliever/Fever Reducer
(pill image) Actual Size
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.
Deer Park, NY 11729
Pain Relief EX 100ct. Caplets
Pain Relief EX 100ct. Caplets
- INGREDIENTS AND APPEARANCE
SOUND BODY EXTRA STRENGTH PAIN RELIEVER
acetaminophen 500 mg tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-913 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 15mm Flavor Imprint Code AZ012 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-913-01 1 in 1 CARTON 12/17/2014 1 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 12/17/2014 Labeler - Allegiant Health (079501930)