Handy Solutions Sinus Congestion and Pain Relief

Manufacturer
Navajo Manufacturing Company Inc. | Ultra Seal Corporation | ULTRAtab Laboratories, Inc.
Effective date
2023-01-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:41:39

Label at a glance#

ProductHandy Solutions Sinus Congestion and Pain Relief
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

• relieves nasal congestion associated with sinusitis • relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • relieves sinus congestion and pressure, helps decongest sinus openings and passages • restores free breathing • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs mo...

Dosage and administration

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed; do not exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer
Expectorant
Decongestant

Uses

INDICATIONS & USAGE SECTION

• relieves nasal congestion associated with sinusitis
• relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• relieves sinus congestion and pressure, helps decongest sinus openings and passages
• restores free breathing
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
Temporarily relieves minor aches, pains and fever associated with:
• headache • common cold • toothache • backache • muscular aches • menstrual cramps

Warnings

WARNINGS SECTION

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 8 tablets in 24 hours
• with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
• 3 or more alcoholic drinks every day while using this product

Do not use

OTC - DO NOT USE SECTION

• with any other product containing acetaminophen. This will provide more than the recommended dose (overdose) of acetaminophen and could
cause serious health concerns

• 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or
pharmacist before taking this product.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

• when using this product do not exceed the recommended dose

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

• heart disease • high blood pressure
• thyroid disease • diabetes
• difficulty in urination due to enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if:

OTC - STOP USE SECTION

• symptoms do not improve
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever
• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed; do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years of age: consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Avoid excessive heat and humidity.
  • Store at controlled room temperatures 15° to 30°C (59° to 86°F).
  • Tamper evident. Do not use if packet is torn, cut or opened.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red #40, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-525-5097

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-17867751-178-02, 67751-178-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f6f69dce-3089-614b-e053-6294a90a28f3d0f24d76-af3b-438f-a367-7f3050ebf15f2023-03-15WarningsExact identifier
spl set id: d0f24d76-af3b-438f-a367-7f3050ebf15f

Reported adverse events (FAERS/openFDA)#

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