COLD MULTI-SYMPTOM- acetaminophen, phenylephrine hcl, dextromethorphan hbr, chlorpheniramine maleate
L&R Distributors, Inc.
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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Select Brand 44-470473C-delisted
Active ingredients (in each caplet)
(Daytime Cold Multi-Symptom)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Active ingredients (in each caplet)
(Nighttime Cold Multi-Symptom)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- sore throat
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- sneezing and runny nose (Nighttime only)
- helps clear nasal passages
- relieves cough to help you sleep (Nighttime only)
- promotes nasal and sinus drainage (Daytime only)
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- more than 4,000 mg in 24 hours, which is the maximum daily amount
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
- diabetes
- thyroid disease
- heart disease
- glaucoma (Nighttime only)
- cough that occurs with too much phlegm (mucus)
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- difficulty in urination due to enlargement of the prostate gland
- 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)
- marked 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
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts
- redness or swelling is present
These could be signs of a serious condition.
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. If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over:
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
-
see end flap for expiration date and lot number
Inactive ingredients (Daytime only)
corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide
Inactive Ingredients (Nighttime only)
corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Principal Display Panel
select brand®
the lower price name brand
NDC 15127-927-24
Cold
Multi-Symptom
Acetaminophen Fever
Sore Throat
Headache
Phenylephrine HCl - Nasal Congestion
Dextromethorphan HBr - Coughing
Daytime
Non-Drowsy
12 COOL CAPLETS
with Cool Blast Flavor
Acetaminophen Fever
Sore Throat
Headache
Phenylephrine HCl - Nasal Congestion
Dextromethorphan HBr - Coughing
Chlorpheniramine maleate - Runny Nose
Nighttime
**Antihistamine in
Nighttime Only
12 COOL CAPLETS
with Cool Blast Flavor
Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Antihistamine**
*Compare to the Active Ingredients of Tylenol® Cold Multi-Symptom
DOES NOT CONTAIN PSEUDOEPHEDRINE
*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Tylenol® Cold Multi-Symptom Daytime and Nighttime.
50844 REV0316D47047308
44-470473C
| COLD MULTI-SYMPTOM
acetaminophen, phenylephrine hcl, dextromethorphan hbr, chlorpheniramine maleate kit |
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| Labeler - L&R Distributors, Inc. (012578514) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(15127-927) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | PACK(15127-927) | |