Search by Drug Name or NDC

NDC 50804-0220-06 sinus pressure and pain pe 325; 5 mg/1; mg/1 Details

sinus pressure and pain pe 325; 5 mg/1; mg/1

sinus pressure and pain pe is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by GOODSENSE. The primary component is ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 50804-0220-06
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 50804-0220-06
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	50804-0220
Product ID	50804-220_ee2958ea-a296-48bd-e053-2995a90a5740
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	sinus pressure and pain pe
Proprietary Name Suffix	n/a
Non-Proprietary Name	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	325; 5
Active Ingredient Units	mg/1; mg/1
Substance Name	ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	GOODSENSE
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50804-0220-06 (50804022006)

Pricing Information	N/A
NDC Package Code	50804-220-06
Billing NDC	50804022006
Package	2 BLISTER PACK in 1 CARTON (50804-220-06) / 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date	2020-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a7931e4c-8a5e-66e2-e053-2995a90af2a4 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- sinus congestion and pressure
- headache
- minor aches and pains
- nasal congestion
promotes sinus drainage
temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) 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

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.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In 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.

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours
children under 12 years	ask a doctor

Other information

store between 20-25ºC (68-77ºF) in a dry place
retain carton for complete product information and warnings

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

GOODSENSE®

NDC 50804-220-06

Maximum Strength

Non-Drowsy

Sinus Pressure + Pain PE

Acetaminophen, Phenylephrine HCl

Pain Reliever / Fever Reducer, Nasal Decongestant

• Sinus Headache

• Sinus Pressure

• Sinus Congestion

24 CAPLETS

Actual Size

Compare to active ingredients of Sudafed PE® Sinus Pressure + Pain†

INGREDIENTS AND APPEARANCE

SINUS PRESSURE AND PAIN PE

acetaminophen and phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-220
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	AAA;1120
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50804-220-06	2 in 1 CARTON	08/01/2020
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/01/2020

Labeler - GOODSENSE (076059836)

Revised: 11/2022

Document Id: ee2958ea-a296-48bd-e053-2995a90a5740

Set id: a7931e4c-8a5e-66e2-e053-2995a90af2a4

Version: 3

Effective Time: 20221123

Search by Drug Name or NDC

NDC 50804-0220-06 sinus pressure and pain pe 325; 5 mg/1; mg/1 Details

sinus pressure and pain pe 325; 5 mg/1; mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 50804-0220-06 (50804022006)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a7931e4c-8a5e-66e2-e053-2995a90af2a4 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Liver warning

Allergy alert

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children.

Overdose warning

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Is Inositol Safe With Ozempic (Semaglutide)?

Can You Take A Z-Pak If You Have A Penicillin Allergy?