SINUS CONGESTION AND PAIN RELIEF- acetaminophen, guaifenesin and phenylephrine hcl 325 mg, 200 mg and 5 mg tablet, coated

SINUS CONGESTION AND PAIN RELIEF by

Drug Labeling and Warnings

SINUS CONGESTION AND PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by We Care Distributor Inc., ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active Ingredient (in each tablet): Purpose
• Acetaminophen 325 mg: Pain reliever/fever reducer
• Guaifenesin 200 mg:

  Expectorant

• Phenylephrine HCl 5 mg:

  Nasal decongestant

Uses

• for the temporary relief of:
• headache
• nasal congestion
• minor aches and pains
• sinus congestion and pressure
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves nasal congestion due to the common cold and hay fever and other upper respiratory allergies
• temporarily reduces fever

Warnings

Liver warning:

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (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

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 monomine 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
• thyroid disease
• diabetes
• high blood pressure
• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis,or emphysema
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)

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, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts

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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 tablets every 4 hours

• swallow whole - do not crush, chew or dissolve

• do not take more than 10 tablets in 24 hours

• children under 12 years: ask a doctor

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

• read all product information before using. Keep this box for important information

Inactive ingredients

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

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

See New Warnings Information & Directions

Compare to the Active Ingredients in

Tylenol® Sinus Congestion & Pain Severe

Acetaminophen, Guaifenesin and Phenylephrine HCl 325 mg, 200 mg and 5 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Tablets Each

INGREDIENTS AND APPEARANCE

SINUS CONGESTION AND PAIN RELIEF 
acetaminophen, guaifenesin and phenylephrine hcl 325 mg, 200 mg and 5 mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-012
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	FR;14
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-012-25	25 in 1 BOX	02/15/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 70005-012-50	50 in 1 BOX	02/15/2016
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 70005-012-02	2 in 1 POUCH	02/15/2016
3		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/15/2016

Labeler - We Care Distributor Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(70005-012)