CONGESTION AND HEADACHE by RETAIL BUSINESS SERVICES , LLC. CAR-1166-2020-0819
CONGESTION AND HEADACHE by
Drug Labeling and Warnings
CONGESTION AND HEADACHE by is a Otc medication manufactured, distributed, or labeled by RETAIL BUSINESS SERVICES , LLC.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
CONGESTION AND HEADACHE- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
RETAIL BUSINESS SERVICES , LLC.
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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CAR-1166-2020-0819
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- temporarily reduces fever
- promotes nasal and/or sinus drainage
- 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 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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.
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
- 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 persistent headache
These could be signs of a serious condition.
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 right away (1-800-222-1222). 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 12 caplets in any 24-hour period
- adults and children 12 years and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Other information
- store between 20-25°C (68-77°F) in a dry place
- retain outer package for complete product information
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL
NDC: 72476-166-02
CAREONE®
Compare to the active ingredients in Mucinex† Fast-Max® Congestion & Headache†
Maximum Strength
CONGESTION + HEADACHE
Pain Reliever/Fever Reducer - Acetaminophen
Expectorant - Guaifenesin
Nasal Decongestant - Phenylephrine HCl
For Ages 12+
FOR RELIEF OF:
Headache + Fever
Nasal + Chest Congestion
Thins + Loosens Mucus
Actual Size
20 CAPLETS
| CONGESTION AND HEADACHE
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated |
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| Labeler - RETAIL BUSINESS SERVICES , LLC. (967989935) |