SINUS RELIEF by CVS Pharmacy / LNK International, Inc. CVS 44-615544-delisted
SINUS RELIEF by
Drug Labeling and Warnings
SINUS RELIEF by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
SINUS RELIEF MAXIMUM STRENGTH DAYTIME AND NIGHTTIME SINUS PAIN- acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl
CVS Pharmacy
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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CVS 44-615544-delisted
Active ingredients (in each caplet)
(Sinus Day)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Active ingredients (in each caplet)
(Sinus Night)
Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg
Uses (Sinus Day)
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- temporarily 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
Uses (Sinus Night)
- temporarily relieves these symptoms of hay fever and the common cold:
- sneezing
- runny nose
- headache
- sore throat
- nasal congestion
- minor aches and pains
- temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes
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 every day while using this product
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. (Sinus Night only)
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 (Sinus Night only)
- with any other product containing diphenhydramine, even one used on skin (Sinus Night only)
Ask a doctor before use if you have
- heart disease
- liver disease
- diabetes
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Sinus Day only)
- cough that occurs with too much phlegm (mucus) (Sinus Day only)
- a breathing problem such as emphysema or chronic bronchitis (Sinus Night only)
- glaucoma (Sinus Night only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Sinus Night only)
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children (Sinus Night only)
- marked drowsiness may occur (Sinus Night only)
- avoid alcoholic drinks (Sinus Night only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Sinus Night only)
- be careful when driving a motor vehicle or operating machinery (Sinus Night only)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion 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 gets worse or lasts more than 7 days (Sinus Day only)
- cough comes back or occurs with rash or headache that lasts (Sinus Day only)
These could be signs of a serious condition.
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 use more than directed (see overdose warning)
-
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 12 caplets in 24 hours
- children under 12 years: do not use
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients (Sinus Day)
corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide
Inactive ingredients (Sinus Night)
corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin
Principal Display Panel
CVS Health™
Compare to the active ingredients in Maximum
Strength Mucinex® SINUS-MAXTM Day & Night*
Sinus Pain
NDC: 59779-881-09
DAYTIME
MAXIMUM STRENGTH
Sinus Relief
ACETAMINOPHEN - Pain reliever
GUAIFENESIN - Expectorant
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Sinus pressure &
Congestion, Headache
Thins & Loosens mucus
Actual
Size
10 CAPLETS
For Ages 12+
NIGHTTIME
MAXIMUM STRENGTH
Sinus Relief
ACETAMINOPHEN - Pain reliever
DIPHENHYDRAMINE HCI - Antihistamine
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Sinus pressure, Pain &
Nasal congestion, Runny
nose & Sneezing
Actual
Size
10 CAPLETS
For Ages 12+
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-19849
*This product is not manufactured or distributed by
Reckitt Benckiser LLC, owner of the registered trademark
Maximum Strength Mucinex® SINUS-MAX™ Day & Night.
50844 ORG041361554409
CVS® Quality
Money Back Guarantee
CVS 44-615544 Carton
CVS 44-615544 Drug Facts (continued)
CVS 44-615544 Drug Facts (continued)
| SINUS RELIEF
MAXIMUM STRENGTH DAYTIME AND NIGHTTIME SINUS PAIN
acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit |
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| Labeler - CVS Pharmacy (062312574) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | PACK(59779-881) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(59779-881) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | PACK(59779-881) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 967626305 | PACK(59779-881) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 868734088 | PACK(59779-881) | |