COLD/FLU MULTI-SYMPTOM RELIEF DAYTIME/NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl
DOLGENCORP, 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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Rexall 44-559-560 Delisted
Active ingredients (in each gelcap) (Daytime Cold Multi-Symptom)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Active ingredients (in each gelcap) (Nighttime Flu Relief)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these common cold and flu symptoms:
- headache
- nasal congestion
- sore throat (Daytime only)
- cough (Daytime only)
- minor aches and pains
- sinus congestion and pressure
- runny nose and sneezing (Nighttime only)
- helps clear nasal passages
- promotes nasal and sinus drainage
- temporarily reduces fever
- temporarily relieves these additional symptoms of hay fever or other upper respiratory allergies: (Nighttime only)
- itching of the nose or throat (Nighttime only)
- itchy, watery eyes (Nighttime only)
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- with other drugs containing acetaminophen
- more than 4,000 mg of acetaminophen in 24 hours
- 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. (Daytime 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
Ask a doctor before use if you have
- liver disease
- diabetes
- thyroid disease
- heart disease
- glaucoma (Nighttime only)
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus) (Daytime only)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- drowsiness may occur (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- use caution when driving a motor vehicle or operating machinery (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
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. (Daytime only)
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time
Directions
- do not take more than directed
- adults and children 12 years and over
- take 2 gelcaps every 4 hours
- do not take more than 10 gelcaps in 24 hours
- children under 12 years: ask a doctor
Other information
- contains FD&C Yellow #5 (tartrazine) as a color additive (Nighttime only)
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive ingredients (Daytime only)
croscarmellose sodium, crospovidone, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silicon dioxide, stearic acid, titanium dioxide
Inactive ingredients (Nighttime only)
corn starch, croscarmellose sodium, crospovidone, FD&C red #3, FD&C red #40, FD&C yellow #5, FD&C yellow #6, gelatin, hydroxypropyl cellulose,
hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, silicon dioxide, stearic acid, titanium dioxide
Principal display panel
Since 1903
Rexall®
NON-DROWSY RAPID RELEASE
RAPID RELEASE
Cold/Flu Multi-Symptom Relief
Daytime Nighttime
ACETAMINOPHEN 325 mg, ACETAMINOPHEN 325 mg,
DEXTROMETHORPHAN HBr 10 mg, CHLORPHENIRAMINE MALEATE 2 mg,
PHENYLEPHRINE HCl 5 mg PHENYLEPHRINE HCl 5 mg
• pain reliever/fever reducer • pain reliever/fever reducer
• cough suppressant • antihistamine
• nasal decongestant • nasal decongestant
Actual Size Actual Size
PSEUDOEPHEDRINE FREE
12 DAYTIME
GELCAPS
12 NIGHTTIME
GELCAPS
24 TOTAL
GELCAPS
COMBO PACK
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
Visit us at: Rexall.com or call 1-866-4-REXALL
MANUFACTURED FOR DOLGENCORP, LLC
100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA
50844 REV0718D55956008
Rexall 44-556560
| COLD/FLU MULTI-SYMPTOM RELIEF
DAYTIME/NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit |
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| Labeler - DOLGENCORP, LLC (068331990) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | pack(55910-956) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | manufacture(55910-956) | |