Daytime cold and flu liquid

Drug facts

Active ingredients (in each15 mL tablespoon)

Acetaminophen, USP325 mg
Dextromethorphan HBr, USP10 mg
Phenylephrine HCl, USP5 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 Parkinsons 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

  • each15 mL contains:sodium49 mg
  • store at 20 to 25C (68 to 77F)

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

Ingredients and appearance - Product information

Daytime cold and flu liquid- Acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 37835-695
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 15 mL
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 10 mgin 15 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 15 mL

Inactive Ingredients

Ingredient Name Code
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) Flavor ORANGE

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 37835-695-30 354mL in 1 BOTTLE 2018/01/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA 2018/01/11

Labeler - Bi-Mart( 027630078)

Establishment

Name ID/FEI Business Operations
Bi-Mart 027630078 MANUFACTURE( 37835-695)

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)