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Day Time Cold and FlueNon drowsy Non drowsy

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Allegiant Health
NDC Code: 69168-356

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 (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

temporarily relieves common cold and flu symptoms:    ■ nasal congestion   ■ cough due to minor throat and bronchial irritation   ■ sore throat   ■ headache   ■ minor aches and pains   ■ fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses 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 reactions. Symptoms may include:   ■ skin reddening   ■ blisters   ■ rash
If a skin 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 products 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 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    ■ persistent or chronic cough such as occurs with smoking, asthma, 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 dosage

Stop use and ask a doctor if

 ■ you get nervous, dizzy or sleepless   ■ symptoms get worse or lasts more than 5 days (children) or 7 days (adults)   ■ fever gets worse or lasts 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 accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). 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)
■ do not exceed 4 doses per 24 hours
■ Adults and children 12 years and over:
take 2 softgels every 4 hours
■ Children 4 to under 12 years: ask a doctor
■ Children under 4 years: do not use this

Other information

■ store at room temperature    ■ do not use if blister is torn or open

Inactive Ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol. May also contain FD&C Yellow #6, titanium dioxide

Questions or comments?

Call toll free 1-888-952-0050

Package/Label Principal Display Panel

 

Health A2Z 356

DAY TIME COLD AND FLUENON DROWSY  NON DROWSY
acetaminophen 325 mg, dextromethorphan hbr 10 mg, phenylephrine hci 5 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-356
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
POVIDONES 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize21mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-356-298 CAPSULE, LIQUID FILLED in 1 BOX
2NDC:69168-356-5120 CAPSULE, LIQUID FILLED in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/03/2015
Labeler - Allegiant Health (079501930)

 
Allegiant Health

Medically reviewed on Jan 8, 2018

Further information

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

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