Cold and Sinus Pain Relief

Manufacturer
Redicare LLC
Effective date
2021-07-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:41:12

Label at a glance#

ProductCold and Sinus Pain Relief
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN, ACETAMINOPHEN
Label structure14 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 freer breathing ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and ...

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: consult a doctor

Label contents#

Full prescribing information#

Active Ingredients (in each tablet) .........................................Purpose

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg ........................................................................................................pain reliever/fever reducer

Guaifenesin 200 mg .....................................................................................................................................expectorant

Phenylephrine HCI 5 mg ...........................................................................................................................decongestant

Uses:

OTC - PURPOSE 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 freer 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

Liver Warning:

WARNINGS SECTION

This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.

Allergy Warning:

WARNINGS SECTION

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:

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. ■ 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 recommended dose ■ 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.

Ask a doctor or pharmacist before use if:

OTC - ASK DOCTOR/PHARMACIST SECTION

■ you are taking the blood thinning drug warfarin.

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 a fever • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

■ liver disease ■ 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 baby,

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: consult a doctor

Other Information

INDICATIONS & USAGE SECTION

■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold TabletsCold Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN3
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD3
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY3
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71105-106-682023-01-30C16284748780-1f386c649-e9fe-0266-e053-dadaa90a7c1aCold Tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71105-106-68Cold and Sinus Pain Relief100 in 1 CARTONTABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71105-106COLD AND SINUS PAIN RELIEF TABLET [REDICARE LLC]3Legacy NDC, 1 package rows20210703_47e07fe1-cd82-6336-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71105-10671105-106-68

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
c62a329f-5088-78ad-e053-2a95a90a9b2a47e07fe1-cd82-6336-e054-00144ff88e882021-07-02WarningsExact identifier
spl id: c62a329f-5088-78ad-e053-2a95a90a9b2a
spl set id: 47e07fe1-cd82-6336-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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