CIRCLE K DAYTIME  COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid 
Lil' Drug Store Products, Inc

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.

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Circle K Daytime
Cold & Flu

Drug Facts

Active ingredients (in each 15 mL, 1 tablespoon)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal 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 tablespoons or 180 mL) in 24 hours for adults
  • more than 5 doses (5 tablespoons 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 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.
  • 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if the user has

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

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

When using this product

Stop use and ask a doctor if

  • redness or swelling is present
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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)
  • do not exceed 5 doses (children) or 6 doses (adults) per 24 hours
  • use dosage cup provided
  • tbsp = tablespoon, mL = milliliter
adults and children 12 years and over2 tablespoons (30 mL) every 4 hours
children 6 to 11 years1 tablespoon (15 mL) every 4 hours
children 4 to 5 yearsdo not use unless directed by a doctor
children under 4 yearsdo not use

  • When using Daytime and Nighttime products, carefully read each label to ensure correct dosing.

Other information

  • each 15 mL contains: sodium 71 mg
  • store at room temperature

Inactive ingredients

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

Questions or comments?

Call 1-877-507-6516 (M-F 8AM-4:30PM CST)

Proudly distributed by
Circle K Stores Inc.

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

Compare to the Active Ingredients in Vicks® DayQuil®*

K®

Daytime Cold & Flu

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI
Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

Relieves

- Aches - Sore Throat - Fever
- Nasal Congestion - Cough

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.

Product manufactured for: Lil' Drug Store Products, Inc.
1201 Continental PIace NE , Cedar Rapids, IA 52402

Proudly distributed by
Circle K Stores Inc.

Original

8 FL OZ (237mL)

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
CIRCLE K DAYTIME   COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-5831
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg  in 15 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 15 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
FD&C Yellow No. 6 (UNII: H77VEI93A8)  
Glycerin (UNII: PDC6A3C0OX)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
Sucrose (UNII: C151H8M554)  
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-5831-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/201412/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/01/201412/31/2017
Labeler - Lil' Drug Store Products, Inc (093103646)

Revised: 12/2017
 
Lil' Drug Store Products, Inc