Label: MEDI FIRST SINUS PAIN AND PRESSURE- acetaminophen, phenylephrine hydrochloride tablet
OTIS CLAPP MYGREX- acetaminophen, phenylephrine hydrochloride tablet
MEDI FIRST PLUS SINUS PAIN AND PRESSURE- acetaminophen, phenylephrine hydrochloride tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 47682-146-13, 47682-146-33, 47682-146-48, 47682-146-50, view more47682-146-99, 47682-148-03, 47682-148-99, 47682-158-33, 47682-158-48 - Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Drug Label Information
Updated March 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- for more than 10 days for pain unless directed by a doctor
Ask a doctor before use if you have
- liver disease
- thyroid disease
- diabetes
- high blood pressure
- heart disease
- trouble urinating due to an enlarged prostate gland
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- Medi-First Plus Sinus Pain and Pressure Label
-
Medi-First Sinus Pain and Pressure Label
250 Tablets
(125 x 2)
Medi-First ®
Sinus Pain and PressureAlivio al dolor y presion en los
senos nasales
Pull to Open
Tire Para AbrirAches & Fever • Acetaminophen 500 mg
Dolores, Fiebre • Acetaminofeno 500 mg
Nasal Decongestant • Phenylephrine HCl 5 mg
Descongestivo nasal • Hidrocloruro de fenilefrina 5 mg
This Package is For Households Without Young Children.
Este Paquete Es Para Hogares Sin Ninos Pequenos.
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Rvidente en Dosis Unitarias
-
Otis Clapp Mygrex Label
Otis Clapp
Quality and Integrity Since 1840
MYGREX ™
Pain Reliever-Decongestant
Advanced Relief
For Sinus/Headaches
See Warnings and Directions on Side PanelThis Package is for Households without Young Children.
Acetaminophen 500 mg • Aches & Fever
Phenylephrine HCl 5 mg • Nasal Decongestant
Tear Out Along Perforation To Dispense
PROFESSIONAL HEALTHCARE
300 Tablets (150 PACKETS OF 2) -
INGREDIENTS AND APPEARANCE
MEDI FIRST SINUS PAIN AND PRESSURE
acetaminophen, phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-146 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color blue (blue) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code FR;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-146-33 50 in 1 BOX 12/30/2008 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-146-48 125 in 1 BOX 12/30/2008 2 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:47682-146-13 250 in 1 BOX 12/30/2008 3 NDC:47682-146-99 2 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:47682-146-99 2 in 1 PACKET; Type 0: Not a Combination Product 12/30/2008 5 NDC:47682-146-50 25 in 1 BOX 04/16/2019 5 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/30/2008 OTIS CLAPP MYGREX
acetaminophen, phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-148 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color blue (blue) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code FR;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-148-03 150 in 1 BOX 12/30/2008 1 NDC:47682-148-99 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-148-99 2 in 1 PACKET; Type 0: Not a Combination Product 12/30/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/30/2008 MEDI FIRST PLUS SINUS PAIN AND PRESSURE
acetaminophen, phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-158 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color blue (blue) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code FR;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-158-33 50 in 1 BOX 12/30/2008 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-158-48 125 in 1 BOX 12/30/2008 2 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/30/2008 Labeler - Unifirst First Aid Corporation (832947092)