OTC Medication Information: Circle K Daytime Cold and Flu

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

Drug Facts

Active ingredients (in each softgel) 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 you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • 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

  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • nervousness, dizziness, or sleeplessness occur
  • 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 can 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 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

  • store between 15°-30°C (59°-86°F)
  • avoid excessive heat

Inactive ingredients

FD&C yellow #6, FD&C red #40, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

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 — 16 Softgel Blister Pack Carton

Compare to the Active Ingredients in
Vicks® DayQuil® LiquiCaps®**

CIRCLE K ®

Daytime Cold & Flu

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

Non-Drowsy Relief of
– Aches — Fever — Sore Throat
– Nasal Congestion — Cough
ACTUAL SIZE

16 Softgels
(Liquid-filled capsules)

PRINCIPAL DISPLAY PANEL -- 16 Softgel Blister Pack Carton
(click image for full-size original)

PDP

TEMPORARILY RELIEVES ACHES, FEVER, SORE THROAT, CONGESTION, COUGH
Compare to the active ingredients in
Vicks® DayQuil® Cold & Flu LiquiCaps®**

CIRCLE K

daytime cold & flu

Acetaminophen 325 mg,
Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg
Pain Reliever/Fever Reducer, Cough Suppressant,
Nasal Decongestant

[softgel image]

actual size

16 softgels*

PDP
(click image for full-size original)
CIRCLE K DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5771
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
FD&C RED NO. 40
GELATIN, UNSPECIFIED
GLYCERIN
LECITHIN, SOYBEAN
LIGHT MINERAL OIL
MANNITOL
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL
Product Characteristics
Color orange Score no score
Shape OVAL Size 20mm
Flavor Imprint Code PC9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-5771-8 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (66715-5771-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 09/05/2014 07/13/2024
CIRCLE K DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5571
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
FD&C RED NO. 40
GELATIN, UNSPECIFIED
GLYCERIN
LECITHIN, SOYBEAN
LIGHT MINERAL OIL
MANNITOL
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL
Product Characteristics
Color orange Score no score
Shape OVAL Size 20mm
Flavor Imprint Code PC9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-5571-8 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (66715-5571-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 08/25/2021
Labeler — Lil’ Drug Store Products, Inc. (093103646)

Revised: 12/2023 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.

Terms of Use | Copyright © 2024. All Rights Reserved.