Sinu-Phen Plus

Product NDC
69103-2546
Requested package NDC
69103-2546-5
11-digit product format
691032546
Labeler code
69103
Product ID
69103-2546_d6c59dc5-5d74-40b6-836c-747ab36a80e9
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl, Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Provision Medical Products
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-03-31
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BSINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJSINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINU-PHEN PLUS (PHENYLEPHRINE HCL, ACETAMINOPHEN ) TABLET [PROVISION MEDICAL PRODUCTS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69103-2546-569103254605250 PACKET in 1 PACKAGE (69103-2546-5) > 2 TABLET in 1 PACKET250 packet2015-04-030000-00-00NoNoCurrent