Walgreens 44-560-Delisted
Cold by
Drug Labeling and Warnings
Cold by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
COLD DAYTIME, MULTI-SYMPTOM, NON-DROWSY- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet
Walgreen Company
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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Walgreens 44-560-Delisted
Active ingredients (in each gelcap)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- nasal congestion
- headache
- cough
- sinus congestion and pressure
- sore throat
- helps clear nasal passages
- promotes nasal and sinus drainage
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 gelcaps (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:
- 3 or more alcoholic drinks every day while using this product
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
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
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, 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
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache
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 take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 gelcaps every 4 hours
- do not take more than 10 gelcaps in 24 hours
- swallow whole; do not crush, chew or dissolve
- 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
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, silica gel, stearic acid, titanium dioxide
Principal Display Panel
Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ
NDC: 0363-0560-07
DAYTIME
MULTI-SYMPTOM
NON-DROWSY
Cold
Acetaminophen / Fever / Headache / Sore Throat
Dextromethorphan HBr / Coughing
Phenylephrine HCl / Nasal Congestion
Pain reliever, fever reducer, cough suppressant &
nasal decongestant
Fast-release Quick Gels™
36
GELCAPS
(24+12 FREE)
Actual Size
Compare to Tylenol® Cold
Multi-Symptom Daytime Rapid
Release Gels active ingredientsǂǂ
PSEUDOEPHEDRINE FREE
ǂWalgreens Pharmacist Survey Study,
November 2012.
ǂǂThis product is not manufactured or distributed
by McNeil Consumer Healthcare, owner of the
registered trademark Tylenol® Cold
Multi-Symptom Daytime Rapid Release Gels.
50844 REV1113B56007
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens
100% SATISFACTION GUARANTEED
walgreens.com ©2014 Walgreen Co.
Walgreens 44-560
| COLD
DAYTIME, MULTI-SYMPTOM, NON-DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet |
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| Labeler - Walgreen Company (008965063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(0363-0560) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | PACK(0363-0560) | |