ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH LIQUID GELS- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled

Alka-Seltzer Plus Severe Sinus Cold and Cough by

Drug Labeling and Warnings

Alka-Seltzer Plus Severe Sinus Cold and Cough by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC., Bayer HealthCare LLC Consumer Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each capsule)

• Active ingredients (in each capsule): Purposes
• Acetaminophen 250 mg: Pain reliever/fever reducer
• Dextromethorphan hydrobromide 10 mg: Cough suppressant
• Guaifenesin 200 mg: Expectorant
• Phenylephrine hydrochloride 5 mg: Nasal decongestant

Purposes

Uses

• temporarily relieves these symptoms due to a cold:

· nasal congestion

· sinus congestion and pressure

· headache

· minor aches and pains

· cough

· sore throat

• temporarily restores freer breathing through the nose
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 capsules in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 monoamine 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
• in children under 12 years of age

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
• cough with excessive phlegm (mucus)

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

WHEN USING

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
• nervousness, dizziness, or sleeplessness occurs

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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 the recommended dose
• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 12 capsules in 24 hours or as directed by a doctor.
• children under 12 years: do not use

Other information

• store at 15-25ºC (59-77ºF)

INACTIVE INGREDIENT

FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol-sorbitan solution, titanium dioxide

QUESTIONS

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALKA-SELTZER PLUS SEVERE SINUS COLD AND COUGH  LIQUID GELS
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0507
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	AS;SM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0507-20	2 in 1 CARTON	01/28/2015
1		20 in 1 BLISTER PACK; 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	01/28/2015

Labeler - Bayer HealthCare LLC. (112117283)

Establishment
Name	Address	ID/FEI	Business Operations
Bayer HealthCare LLC Consumer Care		072827066	pack(0280-0507)