COLD AND SINUS PAIN RELIEF tablet

Cold and Sinus Pain Relief by

Drug Labeling and Warnings

Cold and Sinus Pain Relief by is a Otc medication manufactured, distributed, or labeled by Redicare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

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 make coughs more productive. Temporarily relieves minor aches, pains, and fever associated with: ■ headache ■ common cold ■ toothache ■ backache ■ muscular aches ■ menstrual cramps

Warnings:

Liver Warning:

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:

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 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:

■ you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if:

■ 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:

■ 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,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

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:

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

■ 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:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD AND SINUS PAIN RELIEF 
cold and sinus pain relief tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71105-106
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink (Rose Pink)	Score	no score
Shape	ROUND	Size	12mm
Flavor	CHERRY	Imprint Code	fr8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71105-106-68	100 in 1 CARTON; Type 0: Not a Combination Product	10/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/01/2017

Labeler - Redicare LLC (800149346)

Establishment
Name	Address	ID/FEI	Business Operations
Redicare LLC		800149346	repack(71105-106)