DAY TIME COLD AND FLU COLD AND FLU MULTI SYMPTOM RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl solution

Day Time Cold and Flu by

Drug Labeling and Warnings

Day Time Cold and Flu by is a Otc medication manufactured, distributed, or labeled by We Care Distributor Inc., PURINE PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/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 adult/child takes

 more than 4 doses in 24 hours, which is the maximum daily amount for this product

with other drugs containing acetaminophen

adult has 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or followed by fever, headache, rash, nausea, or vomiting, see 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
• high blood pressure
• diabetes
• thyroid disease
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, or emphysema
• a sodium restricted diet

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• new symptoms occur
• redness or swelling is present
• symptom 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 out of reach of children.

Overdose warning: Taking more than directed cause serious health problems.  In case of overdose, get medical help or contact a Poison Control Center right away. 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 directed – see Overdose warning
• use dose cup
• do not exceed 4 doses per 24 hrs

• adults & children 12 years and over: 30 mL every 4 hrs

• children 6 to under 12 years:           15 mL every 4 hrs

• children under 12 years:                  ask a doctor

When using Day Time and Night Time products; carefully read each label to ensure correct dosing

Other information

• protect from freezing
• each tablespoon contains: sodium 46 mg
• store at room temperature 15-30°C (59-86°F)

Inactive ingredients

citric acid, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

SEE NEW WARNINGS

Compare to DayQuil® Cold & Flu Active Ingredients

Non-Drowsy

DayTime Cold & Flu

Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant Multi-Symptom Relief

Aches, fever - Acetaminophen

Cough - Dextromethorphan HBr

Nasal congestion - Phenylephrine HCl

Alcohol Free and Antihistamine Free

4 FL OZ (120 mL)

INGREDIENTS AND APPEARANCE

DAY TIME COLD AND FLU  COLD AND FLU MULTI SYMPTOM RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-045
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCROSE (UNII: C151H8M554)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	ORANGE (clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-045-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/30/2016

Labeler - We Care Distributor Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
PURINE PHARMA LLC		019950491	manufacture(70005-045)