United States - English - NLM (National Library of Medicine)
PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG-
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.
Active ingredient (in each caplet)
Acetaminophen 500 mg
Pain reliever/fever reducer
for the temporary relief of minor aches and pains due to:
minor pain of arthritis
the common cold
premenstrual and menstrual cramps
temporarily reduces fever
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6
caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
more than 4,000 mg of acetaminophen in 24 hours
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 non prescription). 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
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
Stop use and ask a doctor if
These could be signs of a serious condition.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
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.
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 6 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: ask a doctor
Do not use if imprinted safety seal under cap is broken or missing.
Store at room temperature
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.
Ques tions ?
If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.
Principal Display Panel
PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500
Product T ype
HUMAN OTC DRUG
Ite m Code (Source )
NDC:6 8 0 71-4339 (NDC:516 45-70 5)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)
50 0 mg
Stre ng th
PO VIDO NE (UNII: FZ9 8 9 GH9 4E)
STARCH, CO RN (UNII: O8 232NY3SJ)
SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
no sco re
S hap e
OVAL (white bico nvex caplet)
S iz e
Marketing Start Date
Marketing End Date
NDC:6 8 0 71-4339 -3
30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 3/16 /20 18
NDC:6 8 0 71-4339 -9
9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 3/16 /20 18
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
OTC mo no graph no t final
0 3/27/20 0 6
NuCare Pharmaceuticals,Inc. (010632300)
Ad d re s s
Busine ss Ope rations
0 10 6 3230 0
re pa c k(6 8 0 71-4339 )