COLD MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, coated

Cold Multi-Symptom by

Drug Labeling and Warnings

Cold Multi-Symptom by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer

Cough supressant

Nasal decongestant

Uses

■ temporarily relieves these common cold/flu symptoms:

■ minor aches and pains 

■ headache 

■ sore throat  

■ nasal congestion 

■ cough  

■ sinus congestion and pressure 

■ helps loosen phlegm (mucus) and thin bronchial secretions to 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 caplets in 24 hours, which is the maximum daily amount 

■ with other drugs containing acetaminophen

■ 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 a skin reaction occurs, stop use and seek medical help immediately

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 products containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist  n 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 drugs. If you do not know if your prescription drugs contains an MAOI, ask a doctor or pharmacist.

Ask a doctor before use if you have

■ liver disease 

■ heart disease n high blood pressure 

■ thyroid disease 

■ diabetes 

■ trouble urinating due to an enlarged prostate gland 

■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema n cough that occurs with too much phlegm (mucus)

Ask a doctor before use if you are

taking the blood thinning drug warfarin

When using this product

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

Stop use and ask a doctor if        

■ nervousness, dizziness or sleeplessness occurs 

■ pain gets worse or lasts more than 7 days n fever gets worse or lasts more than 3 days  

■ redness or swelling is present  n new symptoms occur  

■ cough comes back or occurs with rash or headache that lasts 

These could be signs of a serious condition.

Pregnancy/Breastfeeding

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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Taking more than the recommended dose (overdose) may cause liver damage. 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 Warnings)

Adults and children 12 years and over: 

■ take 2 caplets every 4 hours   

■ do not take more than 12 caplets in 24 hours 

Children under 12 years: do not use this adult product in children under 12 years of age.

This will provide more than the recommended dose (overdose) and may cause liver damage

Other information

■ store between 15-30°C (59-86°F) 

■ do not use if blister is torn or open

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropylmethylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-888-952-0050

Principal Display Panel

 

Cold Multi-Symptom

INGREDIENTS AND APPEARANCE

COLD MULTI-SYMPTOM 
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-324
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	AZ;324
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-324-86	1 in 1 CARTON	08/15/2015
1		12 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	08/15/2015

Labeler - Allegiant Health (079501930)