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Day Time with PE by Chain Drug Consortium, LLC

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-142

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 Ingredients

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg

Purposes

Acetaminophen..................................Pain reliever/fever reducer
Dextromethorphan HBr.....................Cough suppressant
Phenylephrine HCI............................Nasal decongestant

Uses

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

Warnings

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 6 doses (12 tablespoonfuls or 180 mL) in 24 hours for adults
• more than 5 doses (5 tablespoonfuls or 75 mL) in 24 hours for
children 6-12 years old
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday 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

• if you are on a sodium-restricted diet
• 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 two 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. • with any other drug containing acetaminophen (prescription or
non-prescription). If you are not sure whether a drug contains acetaminophen, ask a
doctor or pharmacist.

Ask a doctor before use if you have

• liver disease • heart disease • thyroid disease • diabetes • high blood pressure
• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• cough accompanied by excessive phlegm (mucus)
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

When using this product

• avoid alcoholic drinks
• do not use more than directed (see overdose warning)

Stop use and ask a doctor if

• redness or swelling is present • new symptoms occur
• you get nervous, dizzy or sleepless
• pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• fever gets worse or lasts more than 3 days
• 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 this and all drugs out of the reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) could cause
serious health problems, including liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Quick medical
attention is critical for adults as well as for children even if you do not notice any signs
or symptoms.

Directions

• take only as recommended (see overdose warning)
• use dosage cup or tablespoon (TBSP)
• do not exceed 5 doses (children) or 6 doses (adults) per 24 hours
Age Dose
adults and children 12 years and older.........2 tablespoons (30 mL) every 4 hours
children 6 years to under 12 years................ 1 tablespoon (15 mL) every 4 hours
children 4 years to under 6 years...................do not use unless directed by a doctor
children under 4 years.....................................do not use

• When using Day Time and Night Time products, carefully read each
label to ensure correct dosing.

Other Information

• sodium content per tablespoon: 71 mg
• store at controlled room temperature

Inactive Ingredients

citric acid, flavor, glycerin, polyethylene glycol,
propylene glycol, purified water, saccharin sodium, sodium citrate,
sucrose, yellow 6

Principal Display Panel

Premier Value

Day-Time

Non-Drowsy Cold/flu Relief

Acetaminophen

6 FL OZ (177 mL)

Package label

Premier value Daytime with PE

DAY TIME  WITH PE
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-142
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
POLYETHYLENE GLYCOL 300 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM ANHYDROUS 
TRISODIUM CITRATE DIHYDRATE 
SUCROSE 
FD&C YELLOW NO. 6 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (Vicks Dayquil Type Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-142-06177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/03/2009
Labeler - Chain Drug Consortium, LLC (101668460)

 
Chain Drug Consortium, LLC

← See all Day Time with PE brands

Medically reviewed on Oct 23, 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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