MULTI SYMPTOM COLD- acetaminophen, dextromethorphan, phenylephrine, guaifenesin tablet

Multi Symptom Cold by

Drug Labeling and Warnings

Multi Symptom Cold by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each tablet)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

• Pain reliever/fever reducer
• Antitussive
• Expectorant
• Nasal decongestant

Uses

temporarily reduces fever and relieves the following cold symptoms:

• minor aches and pains
• headache
• sore throat
• nasal congestion
• cough

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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

• more than 4,000 mg acetaminophen in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen (prescription or nonprescription).
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If skin reaction occurs, stop use and seek medical help.

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.

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostate
• persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• 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 dose

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 i 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; In case of overdose, get medical help or contact a Poison Control Center right away (1-800-922-1222). Prompt 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 of age and older: take 2 tablets every 6 to 8 hours as needed
• do not exceed 8 tablets in 24 hours, unless directed by a doctor.
• children under 12 years of age: consult a doctor

Other Information

• store at controlled room temperature 15 o-30 oC (59 o-86 oF)
• avoid excessive heat and humidity
• TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

Inactive Ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid

Questions or comments?

1-800-430-5490

MultiSymptom Cold

Multi Symptom Cold

INGREDIENTS AND APPEARANCE

MULTI SYMPTOM COLD 
acetaminophen, dextromethorphan, phenylephrine, guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-1170
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	162 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	orange (BRIGHT ORANGE)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR;12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-1170-50	500 in 1 CARTON	01/02/2017
1	NDC: 0498-1170-01	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0498-1170-10	100 in 1 BOX	01/02/2017
2	NDC: 0498-1170-01	2 in 1 PACKET; 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	01/02/2017

MULTI SYMPTOM COLD 
acetaminophen, dextromethorphan, phenylephrine, guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-1070
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	162 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	orange (BRIGHT ORANGE)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR;12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-1070-50	250 in 1 CARTON	04/24/2012	01/01/2017
1	NDC: 0498-1070-25	125 in 1 CARTON
1	NDC: 0498-1070-10	50 in 1 CARTON
1	NDC: 0498-1070-01	2 in 1 PACKET; 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	04/24/2012	01/01/2017

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	repack(0498-1070, 0498-1170)