Label: CAREONE SEVERE COLD- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
- NDC Code(s): 41520-773-01
- Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated August 7, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
-
Uses
- •
- temporarily relieves these common cold and flu symptoms:
- •
- nasal congestion
- •
- headache
- •
- cough
- •
- minor aches and pains
- •
- sore throat
- •
- temporarily reduces fever
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
-
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.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- diabetes
- •
- high blood pressure
- •
- thyroid disease
- •
- trouble urinating due to an enlarged prostate gland
- •
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- •
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- •
- nervousness, dizziness, or sleeplessness occur
- •
- 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 occurs with rash or headache that lasts. These could be signs of a serious condition.
- Keep out of reach of children.
- Directions
- Inactive ingredients
-
Package/Label Principal Display Panel
Compare to the active ingredients in Mucinex® Fast-Max® Cold & Flu
SEVERE COLD
Pain Reliever/Fever Reducer-Acetaminophen
Cough Suppressant-Dextromethorphan HBr
Expectorant-Guaifenesin
Nasal Decongestant-Phenylephrine HCl
Maximum Strength
Relieves Aches, Fever & Sore Throat
Controls Cough
Relieves Nasal & Chest Congestion
Thins & Loosens Mucus
For Ages 12+
All in one Relief
Gluten Free
Actual Size
OUR PHARMACISTS RECOMMEND
20 CAPLETS
-
INGREDIENTS AND APPEARANCE
CAREONE SEVERE COLD
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-773 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape OVAL Size 20mm Flavor Imprint Code L922 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-773-01 10 in 1 CARTON 04/07/2016 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/07/2016 Labeler - American Sales Company (809183973)