Handy Solutions Cold Relief

Manufacturer
Navajo Manufacturing Company Inc. | Ultra Seal Corporation
Effective date
2023-03-15
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:34:37

Label at a glance#

ProductHandy Solutions Cold Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporarily: • 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 m...

Dosage and administration

Adults and children 12 years of age and older: Take 2 tablets every 6 to 8 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 ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Cough Suppressant

Expectorant

Decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily:
• 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 suppresses cough due to minor throat and bronchial irritation associated with cold or inhaled irritants
Temporarily relieves minor aches, pains and fever associated with:
• headache • backache • common cold • muscular aches
• toothache • 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
• more than the recommended dose
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• 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.

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.

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 enlargement of the 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)

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 6 to 8 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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Label3Label3

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-17767751-177-03, 67751-177-04, 67751-177-05
67751-127

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

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
f6f75dbf-57d3-f769-e053-6394a90ad5b3affddef4-c724-4bf6-8608-6eeffa38d6842023-03-15WarningsExact identifier
spl id: f6f75dbf-57d3-f769-e053-6394a90ad5b3
spl set id: affddef4-c724-4bf6-8608-6eeffa38d684

Reported adverse events (FAERS/openFDA)#

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