CIRCLE K COLD- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet

Circle K Cold by

Drug Labeling and Warnings

Circle K Cold by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 15 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses
- for the temporary relief of the following cold/flu symptoms:
  - minor aches and pains
  - headache
  - sore throat
  - nasal congestion
  - cough
  - impulse to cough
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
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 allergic 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.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
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
- diabetes
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
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, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or is accompanied by a fever, rash or persistent headache
- nervousness, dizziness, or sleeplessness occur.
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. 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 as well as for children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years and over	take 2 tablets with water every 6-8 hours as needed do not take more than 8 tablets in 24 hours, or as directed by a doctor
children under 12 years of age	ask a doctor

Other information
- store at room temperature 59-86° F (15-30° C)
Inactive ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide1, sodium starch glycolate, starch, stearic acid

1 may contain

Questions or comments?

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

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Proudly distributed by Circle K Stores Inc.

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

CIRCLE K®

Cold
severe
congestion

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

ACTUAL SIZE

Non-Drowsy Relief of
- Nasal Congestion
- Sore Throat
- Cough, Impulse to Cough

4 Tablets
2 POUCHES, 2 TABLETS PER POUCH

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

INGREDIENTS AND APPEARANCE

CIRCLE K COLD
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-5728
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	15 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Ingredient Name	Strength
Inactive Ingredients
Maltodextrin (UNII: 7CVR7L4A2D)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Povidone, Unspecified (UNII: FZ989GH94E)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)
Starch, Corn (UNII: O8232NY3SJ)
Stearic Acid (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR12
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 66715-5728-2	2 in 1 CARTON	12/31/2018	11/15/2022
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-5728-3	3 in 1 CARTON	10/15/2019
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	11/01/2014

Labeler - Lil' Drug Store Products, Inc (093103646)