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Cold Multi-Symptom Day-time

Medically reviewed on Dec 25, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, GUAIFENESIN 200mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Allegiant Health
NDC Code: 69168-323

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Acetaminophen 325 mg
Guaifenesin 200 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg

Purpose

Analgesic/Antipyretic
Expectorant
Cough suppressant
Decongestant

Uses

for the temporary relief of the following cold/flu symptoms: •minor aches and pains • headache • sore throat •nasal congestion •cough •impulse to cough 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

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin taking sedatives or tranquilizers

When using this product

do not use exceed recommended dosage

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion or cough gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ 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

In case of overdose, contact a Poison Control Center immediately. 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 and over: take 2 caplets every 4 hours ■ do not take more than a total of 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 recommended dose (overdose) and may cause liver damage

Other Information

store at room temperature 59°-86° F (15°-30° C) do not use if blister is torn or open

Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C Yellow #10, hydroxypropyl methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

Call toll free 1-888-952-0050

Package/Label Principal Display Panel
COLD MULTI-SYMPTOM  DAY-TIME
acetaminophen,guaifenesin, dextromethorphan hbr and phenylephrine hci tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-323
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
HYPROMELLOSES 
SILICON DIOXIDE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
CROSPOVIDONE 
MALTODEXTRIN 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize19mm
FlavorImprint CodeAZ323
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-323-8612 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/23/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930ANALYSIS(69168-323), LABEL(69168-323), MANUFACTURE(69168-323), PACK(69168-323), RELABEL(69168-323), REPACK(69168-323)

 
Allegiant Health

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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