SEVERE COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated
Target Corporation
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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Target 44-677 Delisted
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves common cold and flu symptoms:
- minor aches and pains
- sinus congestion and pressure
- sore throat
- fever
- headache
- nasal congestion
- cough due to minor throat and bronchial irritation
- runny nose and sneezing
- reduces swelling of nasal passages
- promotes nasal and/or sinus drainage
- temporarily restores freer breathing through the nose
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:
- blisters
- rash
- skin reddening
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
- diabetes
- thyroid disease
- heart disease
- glaucoma
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic beverages
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
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.
Directions
- do not take more than directed
- do not take more than 8 caplets in 24 hours
- adults and children 12 years and over: take 2 caplets with water every 4 hours
- children under 12 years: ask a doctor
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
black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Principal display panel
Compare to active ingredients in
Vicks® NyQuil® Severe Cold & Flu*
NDC 11673-677-08
MAX
STRENGTH
nighttime
severe cold and flu
acetaminophen (pain reliever/fever reducer)
dextromethorphan HBr (cough suppressant)
doxylamine succinate (antihistamine)
phenylephrine HCl (nasal decongestant)
aches, fever and sore throat
nasal congestion and cough
sneezing and runny nose
up & up™
24 CAPLETS
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF PACKAGE
IS OPENED OR IF BLISTER UNIT IS TORN,
BROKEN OR SHOWS ANY SIGNS OF
TAMPERING
*This product is not manufactured or
distributed by The Procter & Gamble
Company, owner of the registered
trademark Vicks® NyQuil® Severe
Cold & Flu.
50844 REV0519B67708
Distributed by Target Corporation
Minneapolis, MN 55403
©2019 Target Brands, Inc.
Target 44-677
| SEVERE COLD AND FLU
NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated |
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| Labeler - Target Corporation (006961700) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | pack(11673-677) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | manufacture(11673-677) | |