OTC Medication Information: Circle K Daytime Cold and Flu

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.

Drug Facts

Active ingredients (in each 15 mL) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

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

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if:

  • adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
  • child takes more than 4 doses (15 mL each) 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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
  • a sodium-restricted diet
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult)
  • 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 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) 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

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
adults and children 12 years and over 30 mL every 4 hours
children 6 to under 12 years 15 mL 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 12 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

Call toll free 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®*

CIRCLE K

Daytime Cold & Flu

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

Relieves
– Aches — Sore Throat — Fever
– Nasal Congestion — Cough

Original

8 FL OZ (237mL)

PRINCIPAL DISPLAY PANEL -- 237 mL Bottle Label
(click image for full-size original)
CIRCLE K DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5931
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
GLYCERIN
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM CHLORIDE
TRISODIUM CITRATE DIHYDRATE
SORBITOL
SUCRALOSE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-5931-4 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/01/2014 10/14/2024
Labeler — Lil’ Drug Store Products, Inc. (093103646)

Revised: 11/2021 Lil’ Drug Store Products, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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