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NDC 69842-0505-16 Severe Cold 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 Details
Severe Cold 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Severe Cold is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
Product Information
| NDC | 69842-0505 |
|---|---|
| Product ID | 69842-505_b7e6c6c4-21e6-467e-9a77-ddb8e15b0f24 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Severe Cold |
| Proprietary Name Suffix | Daytime |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 200; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | CVS Pharmacy |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69842-0505-16 (69842050516)
| NDC Package Code | 69842-505-16 |
|---|---|
| Billing NDC | 69842050516 |
| Package | 16 BLISTER PACK in 1 CARTON (69842-505-16) / 1 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2019-12-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 258d27a9-fea6-4076-8dfa-77c7e982d250 Details
Active ingredients (in each softgels)
Uses
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:
- 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.
Ask a doctor before use if you have
- liver disease
- diabetes
- high blood pressure
- heart disease
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking asthma , chronic bronchitis, 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
- fever gets worse, or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with fever, rash, or headache that lasts. 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
Other information
Inactive ingredients
Principal Display Panel
Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Cold Liquid Gel**
Maximum Strength
Severe Cold
Acetaminophen - Pain reliever, Fever reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin- Expectorant
Phenylephrine HCL - Nasal decongestant
MULTI SYMPTOM
- Controls cough
- Thins & loosens mucus
- Relieves nasal & chest congestion
- Relieves aches, fever & sore throat
For Ages 12 +
Alcohol Free
SOFTGELS†
(†Liquid-filled capsules)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Cold Liquid Gels.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com
INGREDIENTS AND APPEARANCE
| SEVERE COLD
DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule |
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| Labeler - CVS Pharmacy (062312574) |