DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

DAYTIME COLD AND FLU by

Drug Labeling and Warnings

DAYTIME COLD AND FLU by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 15 mL tablespoon)

Acetaminophen, USP 325 mg
Dextromethorphan HBr, USP 10 mg
Phenylephrine HCl, USP 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 & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4,000 mg of acetaminophen in 24 hours

• child takes more than 5 doses in 24 hours

•  taken with other drugs containing acetaminophen

•  adult has 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, lasts for more than 2 days, occurs with or is 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

•  thyroid disease

•  diabetes

•  trouble urinating due to 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

When using this product,

do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless

•  symptoms get worse or last 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.

Overdose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

• take only as directed – see Overdose warning

•  use dose cup or tablespoon (TBSP)

•  do not exceed 4 doses (60 mL) (4 TBSP) per 24 hours

•  mL = milliliter; TBSP = tablespoon

• adults & children 12 years & over: 30 mL (2 TBSP) every 4 hours
• children 6 to under 12 years: 15 mL (1 TBSP) every 4 hours
• children 4 to under 6 years: ask a doctor
• children under 4 years: do not use

• when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

• each 15 mL contains: sodium 49 mg
• store at 20° to 25°C (68° to 77°F)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions or comments?

call 1-800-935-6737
 
Distributed by:
BI-MART
Eugene, OR 97402

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -12 FL OZ (354 mL Bottle)

BI-MART
Compare to the active ingredients
in Vicks® DayQuil® COLD & FLU
Multi-Symptom Relief*

Non-drowsy

DAYTIME
COLD & FLU
Multi-Symptom Relief

Acetaminophen USP (Pain reliever/fever reducer)
Phenylephrine HCI USP (Nasal decongestant)
Dextromethorphan HBr USP (Cough suppressant)

• Aches, Fever & Sore Throat
• Nasal Congestion
• Cough 

Alcohol Free/Antihistamine Free

12 FL OZ (354 mL)

INGREDIENTS AND APPEARANCE

DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-695
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ORANGE (UNII: 5EVU04N5QU)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	ORANGE (Orange to Reddish Brown)	Score
Shape		Size
Flavor	APRICOT, ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-695-30	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/11/2018

Labeler - Bi-Mart (027630078)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(37835-695)